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! #
|+ FDA Oncology Approvals & Major Label Updates 2025
! Approval date
! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name
! Medication (Brand)
! Company
! Indication (short)
! Regulatory type
! Trial(s) cited on FDA approval page
! FDA approval reference
 
|-
|-
| 1
| 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma (with bendamustine and rituximab) || ECHO
| 2025-12-17
| Amivantamab + hyaluronidase-lpuj (Rybrevant Faspro)
| Janssen Biotech, Inc.
| Subcutaneous injection across approved amivantamab indications
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 2
| 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Sotorasib (Lumakras)] <br /> Panitumumab (Vectibix) || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300
| 2025-12-17
| Rucaparib (Rubraca)
| pharmaand GmbH
| BRCA-mutated mCRPC after androgen receptor–directed therapy
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 3
| 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-negative breast cancer || TROPION-Breast01
| 2025-12-15
| Fam-trastuzumab deruxtecan-nxki + pertuzumab (Enhertu + Perjeta)
| Daiichi Sankyo, Inc.
| 1L unresectable/metastatic HER2+ breast cancer
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 4
| 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or Treosulfan (Grafapex)] || medac GmbH || Preparative regimen with fludarabine for alloHSCT in AML or MDS || MC-FludT.14/L
| 2025-12-12
| Niraparib + abiraterone acetate + prednisone (Akeega)
| Janssen Biotech, Inc.
| BRCA2-mutated mCSPC
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 5
| 5 || 2025-01-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2 Fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo || Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer || DESTINY-Breast06
| 2025-12-04
| Lisocabtagene maraleucel (Breyanzi)
| Juno Therapeutics, Inc. (BMS)
| R/R marginal zone lymphoma after ≥2 prior lines
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
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| 6
| 6 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic Mirdametinib (Gomekli)] || SpringWorks Therapeutics || NF1-associated symptomatic plexiform neurofibromas (adult & pediatric ≥2 years) || ReNeu
| 2025-12-03
| Pirtobrutinib (Jaypirca)
| Eli Lilly and Company
| R/R CLL/SLL after covalent BTKi
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 7
| 7 || 2025-02-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell Brentuximab vedotin (Adcetris)] || Pfizer || Relapsed or refractory large B-cell lymphoma (with lenalidomide and rituximab) || ECHELON-3
| 2025-11-25
| Durvalumab (Imfinzi) + FLOT → durvalumab
| AstraZeneca
| Resectable gastric/GEJ adenocarcinoma
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
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| 8
| 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera Pharmaceuticals || Symptomatic tenosynovial giant cell tumor (TGCT) || MOTION
| 2025-11-21
| Pembrolizumab (Keytruda/Keytruda Qlex) + enfortumab vedotin (Padcev)
| Merck; Astellas Pharma
| Neoadjuvant + adjuvant for MIBC (cisplatin-ineligible)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
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| 9
| 9 || 2025-03-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma Pembrolizumab (Keytruda)] || Merck || HER2-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) || KEYNOTE-811
| 2025-11-19
| Tarlatamab-dlle (Imdelltra)
| Amgen Inc.
| ES-SCLC after platinum chemotherapy
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 10
| 10 || 2025-03-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet Cabozantinib (Cabometyx)] || Exelixis || Locally advanced or metastatic pNET and epNET (adult & pediatric ≥12 years) || CABINET
| 2025-11-19
| Sevabertinib (Hyrnuo)
| Bayer HealthCare Pharmaceuticals Inc.
| HER2 (ERBB2) TKD–mutated non-squamous NSCLC after prior therapy
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 11
| 11 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer Durvalumab (Imfinzi)] || AstraZeneca || Muscle invasive bladder cancer (neoadjuvant + adjuvant) || NIAGARA
| 2025-11-19
| Daratumumab + hyaluronidase-fihj (Darzalex Faspro) + VCd
| Janssen Biotech Inc.
| Newly diagnosed AL amyloidosis
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 12
| 12 || 2025-03-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)] || Novartis || PSMA-positive mCRPC (expanded indication, earlier-line) || PSMAfore
| 2025-11-19
| Selumetinib (KOSELUGO)
| AstraZeneca Pharmaceuticals LP
| Adults with NF1 + symptomatic inoperable PN
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 13
| 13 || 2025-04-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer Nivolumab (Opdivo) <br /> Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic MSI-H or dMMR colorectal cancer || CheckMate-8HW
| 2025-11-18
| Epcoritamab-bysp (Epkinly)
| Genmab US, Inc.
| Follicular lymphoma indications (combo + mono)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 14
| 14 || 2025-04-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma Nivolumab (Opdivo) <br /> Ipilimumab (Yervoy)] || Bristol Myers Squibb || Unresectable or metastatic hepatocellular carcinoma (first-line) || CheckMate 9DW
| 2025-11-13
| Pertuzumab-dpzb (Poherdy) — interchangeable biosimilar to Perjeta
| Shanghai Henlius Biologics Co. Ltd.
| Interchangeable biosimilar to pertuzumab
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 15
| 15 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma Penpulimab-kcqx] || Akeso Biopharma || Non-keratinizing nasopharyngeal carcinoma (first-line) || AK105-304
| 2025-11-13
| Ziftomenib (Komzifti)
| Kura Oncology, Inc.
| R/R AML with susceptible NPM1 mutation (no satisfactory alternatives)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 16
| 16 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low Avutometinib + Defactinib] || Verastem || KRAS-mutated recurrent low-grade serous ovarian cancer (accelerated) || RAMP 201
| 2025-11-06
| Daratumumab + hyaluronidase-fihj (Darzalex Faspro)
| Janssen Biotech, Inc.
| High-risk smoldering multiple myeloma
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
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| 17
| 17 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || NSCLC with high c-Met overexpression (accelerated) || LUMINOSITY
| 2025-10-24
| Revumenib (Revuforj)
| Syndax Pharmaceuticals, Inc.
| R/R AML with susceptible NPM1 mutation
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 18
| 18 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma Belzutifan (Welireg)] || Merck || Pheochromocytoma or paraganglioma || LITESPARK-016
| 2025-10-23
| Belantamab mafodotin-blmf (Blenrep) + bortezomib + dexamethasone
| GlaxoSmithKline
| R/R multiple myeloma after ≥2 prior lines
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 19
| 19 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma Retifanlimab-dlwr (Zynyz)] || Incyte || Squamous cell carcinoma of the anal canal (combo + monotherapy) || POD1UM-303
| 2025-10-08
| Cemiplimab-rwlc (Libtayo)
| Regeneron Pharmaceuticals Inc.
| Adjuvant CSCC at high risk of recurrence after surgery + radiation
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 20
| 20 || 2025-06-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer Darolutamide (Nubeqa)] || Bayer || Metastatic castration-sensitive prostate cancer (expanded) || ARANOTE
| 2025-10-02
| Lurbinectedin (Zepzelca) + atezolizumab (Tecentriq / Tecentriq Hybreza)
| Jazz Pharmaceuticals, Inc.; Genentech Inc.
| Maintenance for ES-SCLC after induction
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
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| 21
| 21 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer Taletrectinib (Ibtrozi)] || Nuvation Bio || ROS1-positive NSCLC || TRUST-II
| 2025-09-25
| Imlunestrant (Inluriyo)
| Eli Lilly and Company
| ER+, HER2–, ESR1-mutated advanced/metastatic breast cancer after ≥1 endocrine line
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 22
| 22 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck Pembrolizumab (Keytruda)] || Merck || Neoadjuvant and adjuvant resectable locally advanced HNSCC (PD-L1 CPS ≥1) || KEYNOTE-689
| 2025-09-19
| Pembrolizumab + berahyaluronidase alfa-pmph (Keytruda Qlex)
| Merck
| Subcutaneous injection across approved pembrolizumab solid tumor indications
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
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| 23
| 23 || 2025-06-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle Mitomycin intravesical solution (Zusduri)] || UroGen Pharma || Recurrent low-grade intermediate-risk NMIBC || ENVISION
| 2025-09-10
| Selumetinib (KOSELUGO) granules/capsules
| AstraZeneca Pharmaceuticals LP
| Pediatric NF1 + symptomatic inoperable PN (≥1 year)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 24
| 24 || 2025-06-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma Tafasitamab-cxix (Monjuvi)] || Incyte || Relapsed or refractory follicular lymphoma (with lenalidomide + rituximab) || inMIND
| 2025-09-09
| Gemcitabine intravesical system (Inlexzo)
| Janssen Biotech, Inc.
| BCG-unresponsive NMIBC with CIS ± papillary tumors
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
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| 25
| 25 || 2025-06-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || EGFR-mutated locally advanced or metastatic NSCLC (accelerated) || TROPION-Lung01 / TROPION-Lung05
| 2025-08-08
| Zongertinib (Hernexeos)
| Boehringer Ingelheim Pharmaceuticals, Inc.
| HER2 TKD–mutated non-squamous NSCLC after prior therapy
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
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| 26
| 26 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20 Sunvozertinib (Zegfrovy)] || Dizal Pharmaceutical || EGFR exon 20 insertion mutated NSCLC (accelerated) || WU-KONG1B
| 2025-08-06
| Dordaviprone (Modeyso)
| Jazz Pharmaceuticals, Inc.
| Diffuse midline glioma (H3 K27M) progressive after therapy
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
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| 27
| 27 || 2025-07-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma Linvoseltamab-gcpt (Lynozyfic)] || Regeneron || Relapsed or refractory multiple myeloma (≥4 prior lines, accelerated) || LINKER-MM1
| 2025-07-02
| Sunvozertinib (Zegfrovy)
| Dizal (Jiangsu) Pharmaceutical Co., Ltd.
| EGFR exon 20 insertion NSCLC after platinum
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
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| 28
| 28 || 2025-08-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma Dordaviprone (Modeyso)] || Jazz Pharmaceuticals || Diffuse midline glioma (H3 K27M-mutated, accelerated) || Integrated (ONC006/013/014/016/018)
| 2025-06-12
| Mitomycin intravesical solution (Zusduri)
| UroGen Pharma
| Recurrent low-grade intermediate-risk NMIBC
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
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| 29
| 29 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations Zongertinib (Hernexeos)] || Boehringer Ingelheim || HER2-mutated non-squamous NSCLC (accelerated) || Beamion LUNG-1
| 2025-06-11
| Taletrectinib (Ibtrozi)
| Nuvation Bio Inc.
| ROS1+ locally advanced/metastatic NSCLC
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
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| 30
| 30 || 2025-09-09 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer Gemcitabine intravesical system (Inlexzo)] || Janssen || BCG-unresponsive NMIBC with CIS || SunRISe-1
| 2025-06-03
| Darolutamide (Nubeqa)
| Bayer Healthcare Pharmaceuticals Inc.
| Metastatic castration-sensitive prostate cancer
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
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|-
| 31
| 31 || 2025-09-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1 Selumetinib (Koselugo)] || AstraZeneca || Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) || SPRINT
| 2025-05-15
| Retifanlimab-dlwr (Zynyz) + carbo/paclitaxel; also monotherapy
| Incyte Corporation
| Squamous cell carcinoma of the anal canal (SCAC)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 32
| 32 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)] || Merck || Subcutaneous formulation across approved solid tumor indications || MK-3475A-D77
| 2025-05-14
| Telisotuzumab vedotin-tllv (Emrelis)
| AbbVie Inc.
| c-Met high overexpression non-squamous NSCLC after prior therapy
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 33
| 33 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated ER+/HER2− advanced or metastatic breast cancer || EMBER-3
| 2025-05-14
| Belzutifan (Welireg)
| Merck & Co., Inc.
| Locally advanced/unresectable or metastatic PPGL (≥12 years)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 34
| 34 || 2025-10-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive Lurbinectedin (Zepzelca) + Atezolizumab (Tecentriq)] || Jazz / Genentech || Maintenance in extensive-stage small cell lung cancer || IMforte
| 2025-05-08
| Avutometinib + defactinib (Avmapki Fakzynja co-pack)
| Verastem, Inc.
| KRAS-mutated recurrent LGSOC after prior therapy
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 35
| 35 || 2025-10-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma Cemiplimab-rwlc (Libtayo)] || Regeneron || Adjuvant cutaneous squamous cell carcinoma (high-risk) || C-POST
| 2025-04-23
| Penpulimab-kcqx
| Akeso Biopharma Co., Ltd.
| 1L recurrent/metastatic non-keratinizing NPC (with chemo)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 36
| 36 || 2025-10-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma Belantamab mafodotin-blmf (Blenrep)] || GlaxoSmithKline || Relapsed or refractory multiple myeloma (with bortezomib + dexamethasone) || DREAMM-7 / DREAMM-8
| 2025-04-11
| Nivolumab (Opdivo) + ipilimumab (Yervoy)
| Bristol Myers Squibb Company
| 1L unresectable/metastatic HCC
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 37
| 37 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation Revumenib (Revuforj)] || Syndax || NPM1-mutated relapsed or refractory AML (adult & pediatric ≥1 year) || AUGMENT-101
| 2025-04-08
| Nivolumab (Opdivo) + ipilimumab (Yervoy)
| Bristol Myers Squibb Company
| Unresectable/metastatic MSI-H/dMMR CRC (≥12 years)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 38
| 38 || 2025-11-06 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma Daratumumab and hyaluronidase-fihj (Darzalex Faspro)] || Janssen || High-risk smoldering multiple myeloma || AQUILA
| 2025-03-28
| Durvalumab (Imfinzi) + gem/cis → durvalumab
| AstraZeneca
| Muscle invasive bladder cancer (perioperative)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 39
| 39 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation Ziftomenib (Komzifti)] || Kura Oncology || NPM1-mutated relapsed or refractory AML || KOMET-001
| 2025-03-28
| Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) — indication expansion
| Novartis Pharmaceuticals Corporation
| PSMA+ mCRPC (earlier-line)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 40
| 40 || 2025-11-13 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta Pertuzumab-dpzb (Poherdy)] || Shanghai Henlius Biologics || Interchangeable biosimilar to Perjeta || Biosimilarity studies
| 2025-03-19
| Mosunetuzumab-axgb (Lunsumio)
| Genentech, Inc.
| FL after ≥2 prior systemic therapies (peds/adults)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 41
| 41 || 2025-11-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications Epcoritamab-bysp (Epkinly)] || Genmab || Relapsed or refractory follicular lymphoma (combo + monotherapy) || EPCORE FL-1
| 2025-03-14
| Tislelizumab-jsgr (Tevimbra)
| BeiGene, Ltd.
| Unresectable/metastatic ESCC (with platinum/fluoropyrimidine)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 42
| 42 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform Selumetinib (Koselugo)] || AstraZeneca || Adults with NF1-associated symptomatic, inoperable plexiform neurofibromas || SPRINT
| 2025-03-11
| Nivolumab (Opdivo) + chemo
| Bristol Myers Squibb Company
| 1L unresectable/advanced or metastatic gastric/GEJ adenocarcinoma
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 43
| 43 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-daratumumab-and-hyaluronidase-fihj-newly-diagnosed-light-chain Daratumumab and hyaluronidase-fihj (Darzalex Faspro)] || Janssen || Newly diagnosed light chain amyloidosis (traditional approval) || ANDROMEDA
| 2025-03-11
| Pembrolizumab (Keytruda) + lenvatinib (Lenvima)
| Merck; Eisai Inc.
| Primary advanced/recurrent endometrial carcinoma
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 44
| 44 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer Sevabertinib (Hyrnuo)] || Bayer || HER2-mutated non-squamous NSCLC (accelerated) || SOHO-01
| 2025-03-11
| Pembrolizumab (Keytruda) + trastuzumab + chemo
| Merck; Genentech, Inc.
| 1L HER2+ unresectable/advanced or metastatic gastric/GEJ adenocarcinoma
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 45
| 45 || 2025-11-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer Tarlatamab-dlle (Imdelltra)] || Amgen || Extensive-stage small cell lung cancer (traditional approval) || DeLLphi-301
| 2025-03-07
| Durvalumab (Imfinzi) + chemo
| AstraZeneca
| 1L ES-SCLC
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 46
| 46 || 2025-11-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer Pembrolizumab (Keytruda) + Enfortumab vedotin-ejfv (Padcev)] || Merck / Astellas || Muscle invasive bladder cancer (cisplatin-ineligible) || KEYNOTE-A39 / EV-303
| 2025-02-14
| Talquetamab-tgvs (Talvey)
| Janssen Biotech, Inc.
| R/R multiple myeloma (new dosing schedule)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 47
| 47 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric or GEJ adenocarcinoma (perioperative) || MATTERHORN
| 2025-02-13
| Tislelizumab-jsgr (Tevimbra)
| BeiGene, Ltd.
| 1L metastatic NSCLC (with pemetrexed/platinum)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 48
| 48 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic Pirtobrutinib (Jaypirca)] || Eli Lilly || Relapsed or refractory CLL/SLL (traditional approval) || BRUIN
| 2025-02-12
| Brentuximab vedotin (Adcetris) + lenalidomide + rituximab
| Seagen Inc. (Pfizer)
| R/R LBCL after ≥2 lines (HSCT/CAR-T ineligible)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 49
| 49 || 2025-12-04 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma Lisocabtagene maraleucel (Breyanzi)] || Bristol Myers Squibb || Relapsed or refractory marginal zone lymphoma (≥2 prior therapies) || TRANSCEND-FL
| 2025-02-11
| Mirdametinib (Gomekli)
| SpringWorks Therapeutics, Inc.
| NF1 with symptomatic PN not amenable to resection (≥2 years)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 50
| 50 || 2025-12-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration Niraparib + Abiraterone acetate (Akeega)] || Janssen || BRCA2-mutated metastatic castration-sensitive prostate cancer || MAGNITUDE
| 2025-02-06
| Treosulfan (Grafapex) + fludarabine
| medac GmbH
| Preparative regimen for alloHSCT in AML/MDS
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 51
| 51 || 2025-12-15 || [https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive Fam-trastuzumab deruxtecan-nxki (Enhertu) + Pertuzumab] || Daiichi Sankyo || First-line unresectable or metastatic HER2-positive breast cancer || DESTINY-Breast09
| 2025-01-27
| Fam-trastuzumab deruxtecan-nxki (Enhertu)
| Daiichi Sankyo, Inc.
| HR+ HER2-low/ultralow metastatic breast cancer after endocrine therapy
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 52
| 52 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro)] || Janssen || Subcutaneous formulation across approved NSCLC indications || PALOMA-3
| 2025-01-17
| Datopotamab deruxtecan-dlnk (Datroway)
| Daiichi Sankyo, Inc.
| HR+, HER2– metastatic breast cancer after endocrine + chemo
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
|-
| 53
| 53 || 2025-12-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer Rucaparib (Rubraca)] || pharma& GmbH || BRCA-mutated metastatic castration-resistant prostate cancer (regular approval) || TRITON3
| 2025-01-16
| Sotorasib + panitumumab (Lumakras + Vectibix)
| Amgen Inc.
| KRAS G12C-mutated mCRC after fluoropyrimidine/oxaliplatin/irinotecan
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
 
|-
| 54
| 2025-01-16
| Acalabrutinib + bendamustine + rituximab (Calquence-based regimen)
| AstraZeneca
| Previously untreated mantle cell lymphoma (HSCT-ineligible)
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Trials]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Reference]
|}
|}

Latest revision as of 11:03, 1 January 2026

FDA Oncology Approvals & Major Label Updates 2025
# Approval Date Medication (Brand Name) Company Indication Clinical Trial Name
1 2025-01-16 Acalabrutinib (Calquence) AstraZeneca Previously untreated mantle cell lymphoma (with bendamustine and rituximab) ECHO
2 2025-01-16 Sotorasib (Lumakras)
Panitumumab (Vectibix)		 Amgen KRAS G12C–mutated metastatic colorectal cancer CodeBreaK 300
3 2025-01-17 Datopotamab deruxtecan-dlnk (Datroway) Daiichi Sankyo Unresectable or metastatic HR-positive, HER2-negative breast cancer TROPION-Breast01
4 2025-01-21 Treosulfan (Grafapex) medac GmbH Preparative regimen with fludarabine for alloHSCT in AML or MDS MC-FludT.14/L
5 2025-01-27 Fam-trastuzumab deruxtecan-nxki (Enhertu) Daiichi Sankyo Unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer DESTINY-Breast06
6 2025-02-11 Mirdametinib (Gomekli) SpringWorks Therapeutics NF1-associated symptomatic plexiform neurofibromas (adult & pediatric ≥2 years) ReNeu
7 2025-02-12 Brentuximab vedotin (Adcetris) Pfizer Relapsed or refractory large B-cell lymphoma (with lenalidomide and rituximab) ECHELON-3
8 2025-02-14 Vimseltinib (Romvimza) Deciphera Pharmaceuticals Symptomatic tenosynovial giant cell tumor (TGCT) MOTION
9 2025-03-19 Pembrolizumab (Keytruda) Merck HER2-positive gastric or GEJ adenocarcinoma (PD-L1 CPS ≥1, first-line) KEYNOTE-811
10 2025-03-26 Cabozantinib (Cabometyx) Exelixis Locally advanced or metastatic pNET and epNET (adult & pediatric ≥12 years) CABINET
11 2025-03-28 Durvalumab (Imfinzi) AstraZeneca Muscle invasive bladder cancer (neoadjuvant + adjuvant) NIAGARA
12 2025-03-28 Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) Novartis PSMA-positive mCRPC (expanded indication, earlier-line) PSMAfore
13 2025-04-08 Nivolumab (Opdivo)
Ipilimumab (Yervoy)		 Bristol Myers Squibb Unresectable or metastatic MSI-H or dMMR colorectal cancer CheckMate-8HW
14 2025-04-11 Nivolumab (Opdivo)
Ipilimumab (Yervoy)		 Bristol Myers Squibb Unresectable or metastatic hepatocellular carcinoma (first-line) CheckMate 9DW
15 2025-04-23 Penpulimab-kcqx Akeso Biopharma Non-keratinizing nasopharyngeal carcinoma (first-line) AK105-304
16 2025-05-08 Avutometinib + Defactinib Verastem KRAS-mutated recurrent low-grade serous ovarian cancer (accelerated) RAMP 201
17 2025-05-14 Telisotuzumab vedotin-tllv (Emrelis) AbbVie NSCLC with high c-Met overexpression (accelerated) LUMINOSITY
18 2025-05-14 Belzutifan (Welireg) Merck Pheochromocytoma or paraganglioma LITESPARK-016
19 2025-05-15 Retifanlimab-dlwr (Zynyz) Incyte Squamous cell carcinoma of the anal canal (combo + monotherapy) POD1UM-303
20 2025-06-03 Darolutamide (Nubeqa) Bayer Metastatic castration-sensitive prostate cancer (expanded) ARANOTE
21 2025-06-11 Taletrectinib (Ibtrozi) Nuvation Bio ROS1-positive NSCLC TRUST-II
22 2025-06-12 Pembrolizumab (Keytruda) Merck Neoadjuvant and adjuvant resectable locally advanced HNSCC (PD-L1 CPS ≥1) KEYNOTE-689
23 2025-06-12 Mitomycin intravesical solution (Zusduri) UroGen Pharma Recurrent low-grade intermediate-risk NMIBC ENVISION
24 2025-06-18 Tafasitamab-cxix (Monjuvi) Incyte Relapsed or refractory follicular lymphoma (with lenalidomide + rituximab) inMIND
25 2025-06-23 Datopotamab deruxtecan-dlnk (Datroway) Daiichi Sankyo EGFR-mutated locally advanced or metastatic NSCLC (accelerated) TROPION-Lung01 / TROPION-Lung05
26 2025-07-02 Sunvozertinib (Zegfrovy) Dizal Pharmaceutical EGFR exon 20 insertion mutated NSCLC (accelerated) WU-KONG1B
27 2025-07-02 Linvoseltamab-gcpt (Lynozyfic) Regeneron Relapsed or refractory multiple myeloma (≥4 prior lines, accelerated) LINKER-MM1
28 2025-08-06 Dordaviprone (Modeyso) Jazz Pharmaceuticals Diffuse midline glioma (H3 K27M-mutated, accelerated) Integrated (ONC006/013/014/016/018)
29 2025-08-08 Zongertinib (Hernexeos) Boehringer Ingelheim HER2-mutated non-squamous NSCLC (accelerated) Beamion LUNG-1
30 2025-09-09 Gemcitabine intravesical system (Inlexzo) Janssen BCG-unresponsive NMIBC with CIS SunRISe-1
31 2025-09-10 Selumetinib (Koselugo) AstraZeneca Pediatric NF1-associated symptomatic, inoperable plexiform neurofibromas (≥1 year) SPRINT
32 2025-09-19 Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) Merck Subcutaneous formulation across approved solid tumor indications MK-3475A-D77
33 2025-09-25 Imlunestrant (Inluriyo) Eli Lilly ESR1-mutated ER+/HER2− advanced or metastatic breast cancer EMBER-3
34 2025-10-02 Lurbinectedin (Zepzelca) + Atezolizumab (Tecentriq) Jazz / Genentech Maintenance in extensive-stage small cell lung cancer IMforte
35 2025-10-08 Cemiplimab-rwlc (Libtayo) Regeneron Adjuvant cutaneous squamous cell carcinoma (high-risk) C-POST
36 2025-10-23 Belantamab mafodotin-blmf (Blenrep) GlaxoSmithKline Relapsed or refractory multiple myeloma (with bortezomib + dexamethasone) DREAMM-7 / DREAMM-8
37 2025-10-24 Revumenib (Revuforj) Syndax NPM1-mutated relapsed or refractory AML (adult & pediatric ≥1 year) AUGMENT-101
38 2025-11-06 Daratumumab and hyaluronidase-fihj (Darzalex Faspro) Janssen High-risk smoldering multiple myeloma AQUILA
39 2025-11-13 Ziftomenib (Komzifti) Kura Oncology NPM1-mutated relapsed or refractory AML KOMET-001
40 2025-11-13 Pertuzumab-dpzb (Poherdy) Shanghai Henlius Biologics Interchangeable biosimilar to Perjeta Biosimilarity studies
41 2025-11-18 Epcoritamab-bysp (Epkinly) Genmab Relapsed or refractory follicular lymphoma (combo + monotherapy) EPCORE FL-1
42 2025-11-19 Selumetinib (Koselugo) AstraZeneca Adults with NF1-associated symptomatic, inoperable plexiform neurofibromas SPRINT
43 2025-11-19 Daratumumab and hyaluronidase-fihj (Darzalex Faspro) Janssen Newly diagnosed light chain amyloidosis (traditional approval) ANDROMEDA
44 2025-11-19 Sevabertinib (Hyrnuo) Bayer HER2-mutated non-squamous NSCLC (accelerated) SOHO-01
45 2025-11-19 Tarlatamab-dlle (Imdelltra) Amgen Extensive-stage small cell lung cancer (traditional approval) DeLLphi-301
46 2025-11-21 Pembrolizumab (Keytruda) + Enfortumab vedotin-ejfv (Padcev) Merck / Astellas Muscle invasive bladder cancer (cisplatin-ineligible) KEYNOTE-A39 / EV-303
47 2025-11-25 Durvalumab (Imfinzi) AstraZeneca Resectable gastric or GEJ adenocarcinoma (perioperative) MATTERHORN
48 2025-12-03 Pirtobrutinib (Jaypirca) Eli Lilly Relapsed or refractory CLL/SLL (traditional approval) BRUIN
49 2025-12-04 Lisocabtagene maraleucel (Breyanzi) Bristol Myers Squibb Relapsed or refractory marginal zone lymphoma (≥2 prior therapies) TRANSCEND-FL
50 2025-12-12 Niraparib + Abiraterone acetate (Akeega) Janssen BRCA2-mutated metastatic castration-sensitive prostate cancer MAGNITUDE
51 2025-12-15 Fam-trastuzumab deruxtecan-nxki (Enhertu) + Pertuzumab Daiichi Sankyo First-line unresectable or metastatic HER2-positive breast cancer DESTINY-Breast09
52 2025-12-17 Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) Janssen Subcutaneous formulation across approved NSCLC indications PALOMA-3
53 2025-12-17 Rucaparib (Rubraca) pharma& GmbH BRCA-mutated metastatic castration-resistant prostate cancer (regular approval) TRITON3
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