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FDA Oncology Approvals 2025: Difference between revisions

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{| class="wikitable sortable" style="width:100%; text-align:center;"
{| class="wikitable sortable" style="width:100%; text-align:left;"
! #
! Approval date
! Approval date
! Medication (Brand)
! Medication (Brand)
! Company
! Company
! Indication
! Indication (short)
! Regulatory type
! Regulatory type
! Trial(s) cited on FDA approval page
! Trial(s) cited on FDA approval page
! FDA approval reference
|-
|-
| 2025-01-16
| 1
| Sotorasib + Panitumumab<br/>(Lumakras + Vectibix)
| 2025-12-17
| Amgen
| Amivantamab + hyaluronidase-lpuj (Rybrevant Faspro)
| KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
| 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
| 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
| 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
| 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
| 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]
 
|-
| 6
| 2025-12-03
| Pirtobrutinib (Jaypirca)
| Eli Lilly and Company
| R/R CLL/SLL after covalent BTKi
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer CodeBreaK 300]
| [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]
 
|-
|-
| 2025-01-16
| 7
| Acalabrutinib + Bendamustine + Rituximab<br/>(Calquence-based regimen)
| 2025-11-25
| Durvalumab (Imfinzi) + FLOT → durvalumab
| AstraZeneca
| AstraZeneca
| Previously untreated mantle cell lymphoma in adults not eligible for autologous HSCT
| 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]
 
|-
| 8
| 2025-11-21
| Pembrolizumab (Keytruda/Keytruda Qlex) + enfortumab vedotin (Padcev)
| Merck; Astellas Pharma
| Neoadjuvant + adjuvant for MIBC (cisplatin-ineligible)
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-mantle-cell-lymphoma ELEVATE-TN]
| [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]
 
|-
|-
| 2025-01-17
| 9
| Datopotamab deruxtecan-dlnk<br/>(Datroway)
| 2025-11-19
| Daiichi Sankyo
| Tarlatamab-dlle (Imdelltra)
| HR-positive, HER2-negative unresectable or metastatic breast cancer after endocrine therapy and chemotherapy
| 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
| 2025-11-19
| Sevabertinib (Hyrnuo)
| Bayer HealthCare Pharmaceuticals Inc.
| HER2 (ERBB2) TKD–mutated non-squamous NSCLC after prior therapy
| Accelerated approval
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-breast-cancer TROPION-Breast01]
| [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
| 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
| 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
| 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
| 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
| 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]
 
|-
|-
| 2025-01-30
| 16
| Treosulfan + Fludarabine<br/>(Grafapex)
| 2025-11-06
| Medac GmbH
| Daratumumab + hyaluronidase-fihj (Darzalex Faspro)
| Conditioning regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS
| Janssen Biotech, Inc.
| High-risk smoldering multiple myeloma
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-conditioning-allogeneic-hematopoietic-stem-cell-transplantation MC-FludT.14/L]
| [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]
 
|-
|-
| 2025-02-11
| 17
| Mirdametinib<br/>(Gomekli)
| 2025-10-24
| SpringWorks Therapeutics
| Revumenib (Revuforj)
| Adults and children ≥2 years with NF1-associated plexiform neurofibromas
| 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
| 2025-10-23
| Belantamab mafodotin-blmf (Blenrep) + bortezomib + dexamethasone
| GlaxoSmithKline
| R/R multiple myeloma after ≥2 prior lines
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-neurofibromatosis-type-1 ReNeu]
| [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]
 
|-
|-
| 2025-02-14
| 19
| Brentuximab vedotin + Lenalidomide + Rituximab
| 2025-10-08
| Seagen / Bristol Myers Squibb
| Cemiplimab-rwlc (Libtayo)
| Relapsed or refractory diffuse large B-cell lymphoma
| Regeneron Pharmaceuticals Inc.
| Adjuvant CSCC at high risk of recurrence after surgery + radiation
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-rituximab-dlbcl ECHELON-3]
| [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]
 
|-
|-
| 2025-03-05
| 20
| Pembrolizumab + Trastuzumab + Chemotherapy
| 2025-10-02
| Merck & Co.
| Lurbinectedin (Zepzelca) + atezolizumab (Tecentriq / Tecentriq Hybreza)
| HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma
| Jazz Pharmaceuticals, Inc.; Genentech Inc.
| Maintenance for ES-SCLC after induction
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-trastuzumab-gastric-cancer KEYNOTE-811]
| [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]
 
|-
|-
| 2025-03-14
| 21
| Cabozantinib<br/>(Cabometyx)
| 2025-09-25
| Exelixis
| Imlunestrant (Inluriyo)
| Previously treated metastatic pancreatic neuroendocrine tumors
| Eli Lilly and Company
| ER+, HER2–, ESR1-mutated advanced/metastatic breast cancer after ≥1 endocrine line
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-pancreatic-neuroendocrine-tumors CABINET]
| [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]
 
|-
|-
| 2025-04-08
| 22
| Nivolumab + Ipilimumab
| 2025-09-19
| Bristol Myers Squibb
| Pembrolizumab + berahyaluronidase alfa-pmph (Keytruda Qlex)
| MSI-H or dMMR metastatic colorectal cancer
| Merck
| Subcutaneous injection across approved pembrolizumab solid tumor indications
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-msi-h-colorectal-cancer CheckMate-8HW]
| [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]
 
|-
|-
| 2025-05-02
| 23
| Avutometinib + Defactinib
| 2025-09-10
| Verastem Oncology
| Selumetinib (KOSELUGO) granules/capsules
| KRAS-mutated recurrent low-grade serous ovarian cancer
| AstraZeneca Pharmaceuticals LP
| Accelerated approval
| Pediatric NF1 + symptomatic inoperable PN (≥1 year)
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-avutometinib-defactinib-ovarian-cancer RAMP-201]
| 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]
 
|-
|-
| 2025-05-14
| 24
| Belzutifan<br/>(Welireg)
| 2025-09-09
| Merck & Co.
| Gemcitabine intravesical system (Inlexzo)
| Advanced sporadic clear cell renal cell carcinoma
| Janssen Biotech, Inc.
| BCG-unresponsive NMIBC with CIS ± papillary tumors
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-advanced-clear-cell-renal-cell-carcinoma LITESPARK-005]
| [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]
 
|-
|-
| 2025-06-13
| 25
| Datopotamab deruxtecan-dlnk<br/>(Datroway)
| 2025-08-08
| Daiichi Sankyo
| Zongertinib (Hernexeos)
| EGFR-mutated locally advanced or metastatic NSCLC after EGFR-directed therapy and platinum chemotherapy
| Boehringer Ingelheim Pharmaceuticals, Inc.
| HER2 TKD–mutated non-squamous NSCLC after prior therapy
| Accelerated approval
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer TROPION-Lung01]<br/>[https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer TROPION-Lung05]
| [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]
 
|-
|-
| 2025-07-02
| 26
| Sunvozertinib<br/>(Zegfrovy)
| 2025-08-06
| Dizal Pharma
| Dordaviprone (Modeyso)
| EGFR exon 20 insertion–mutated metastatic NSCLC after platinum chemotherapy
| Jazz Pharmaceuticals, Inc.
| Diffuse midline glioma (H3 K27M) progressive after therapy
| Accelerated approval
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20 WU-KONG1B]
| [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]
 
|-
|-
| 27
| 2025-07-02
| 2025-07-02
| Linvoseltamab-gcpt<br/>(Lynozyfic)
| Sunvozertinib (Zegfrovy)
| Regeneron Pharmaceuticals
| Dizal (Jiangsu) Pharmaceutical Co., Ltd.
| Relapsed or refractory multiple myeloma after ≥4 prior lines of therapy
| EGFR exon 20 insertion NSCLC after platinum
| Accelerated approval
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma LINKER-MM1]
| [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]
 
|-
| 28
| 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]
 
|-
| 29
| 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]
 
|-
|-
| 2025-08-08
| 30
| Zongertinib<br/>(Hernexeos)
| 2025-06-03
| Boehringer Ingelheim
| Darolutamide (Nubeqa)
| HER2-mutated non-squamous NSCLC after prior systemic therapy
| 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]
 
|-
| 31
| 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
| 2025-05-14
| Telisotuzumab vedotin-tllv (Emrelis)
| AbbVie Inc.
| c-Met high overexpression non-squamous NSCLC after prior therapy
| Accelerated approval
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations Beamion LUNG-1]
| [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]
 
|-
|-
| 2025-09-25
| 33
| Imlunestrant (Inluriiyo)
| 2025-05-14
| Eli Lilly
| Belzutifan (Welireg)
| ESR1-mutated ER+/HER2– metastatic breast cancer
| Merck & Co., Inc.
| Locally advanced/unresectable or metastatic PPGL (≥12 years)
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-esr1-mutated-metastatic-breast-cancer EMBER-3]
| [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]
 
|-
|-
| 2025-10-24
| 34
| Revumenib (Revuforj)
| 2025-05-08
| Syndax Pharmaceuticals
| Avutometinib + defactinib (Avmapki Fakzynja co-pack)
| Relapsed or refractory NPM1-mutated acute myeloid leukemia
| Verastem, Inc.
| KRAS-mutated recurrent LGSOC after prior therapy
| Accelerated approval
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-revumenib-npm1-mutated-acute-myeloid-leukemia AUGMENT-101]
| [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]
 
|-
|-
| 2025-11-13
| 35
| Ziftomenib (Komzifti)
| 2025-04-23
| Kura Oncology
| Penpulimab-kcqx
| Relapsed or refractory NPM1-mutated acute myeloid leukemia
| Akeso Biopharma Co., Ltd.
| Accelerated approval
| 1L recurrent/metastatic non-keratinizing NPC (with chemo)
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-ziftomenib-npm1-mutated-acute-myeloid-leukemia KOMET-001]
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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]
 
|-
|-
| 2025-11-18
| 51
| Epcoritamab-bysp (Epkinly)
| 2025-01-27
| Genmab
| Fam-trastuzumab deruxtecan-nxki (Enhertu)
| Relapsed or refractory follicular lymphoma
| Daiichi Sankyo, Inc.
| HR+ HER2-low/ultralow metastatic breast cancer after endocrine therapy
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-relapsed-or-refractory-follicular-lymphoma EPCORE-NHL-1]
| [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]
 
|-
|-
| 2025-12-03
| 52
| Pirtobrutinib<br/>(Jaypirca)
| 2025-01-17
| Eli Lilly and Company
| Datopotamab deruxtecan-dlnk (Datroway)
| Relapsed or refractory CLL/SLL after prior covalent BTK inhibitor
| Daiichi Sankyo, Inc.
| HR+, HER2– metastatic breast cancer after endocrine + chemo
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic BRUIN-CLL-321]
| [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]
 
|-
|-
| 2025-12-04
| 53
| Lisocabtagene maraleucel<br/>(Breyanzi)
| 2025-01-16
| Bristol Myers Squibb
| Sotorasib + panitumumab (Lumakras + Vectibix)
| Relapsed or refractory marginal zone lymphoma after ≥2 prior therapies
| Amgen Inc.
| KRAS G12C-mutated mCRC after fluoropyrimidine/oxaliplatin/irinotecan
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma TRANSCEND FL-MZL]
| [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]
 
|-
|-
| 2025-12-12
| 54
| Niraparib + Abiraterone acetate + Prednisone<br/>(Akeega)
| 2025-01-16
| Janssen Biotech
| Acalabrutinib + bendamustine + rituximab (Calquence-based regimen)
| BRCA2-mutated metastatic castration-sensitive prostate cancer
| AstraZeneca
| Previously untreated mantle cell lymphoma (HSCT-ineligible)
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration AMPLITUDE]
| [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]
|}
|}

Revision as of 20:53, 31 December 2025

# Approval date Medication (Brand) Company Indication (short) Regulatory type Trial(s) cited on FDA approval page FDA approval reference
1 2025-12-17 Amivantamab + hyaluronidase-lpuj (Rybrevant Faspro) Janssen Biotech, Inc. Subcutaneous injection across approved amivantamab indications Traditional approval Trials Reference
2 2025-12-17 Rucaparib (Rubraca) pharmaand GmbH BRCA-mutated mCRPC after androgen receptor–directed therapy Traditional approval Trials Reference
3 2025-12-15 Fam-trastuzumab deruxtecan-nxki + pertuzumab (Enhertu + Perjeta) Daiichi Sankyo, Inc. 1L unresectable/metastatic HER2+ breast cancer Traditional approval Trials Reference
4 2025-12-12 Niraparib + abiraterone acetate + prednisone (Akeega) Janssen Biotech, Inc. BRCA2-mutated mCSPC Traditional approval Trials Reference
5 2025-12-04 Lisocabtagene maraleucel (Breyanzi) Juno Therapeutics, Inc. (BMS) R/R marginal zone lymphoma after ≥2 prior lines Traditional approval Trials Reference
6 2025-12-03 Pirtobrutinib (Jaypirca) Eli Lilly and Company R/R CLL/SLL after covalent BTKi Traditional approval Trials Reference
7 2025-11-25 Durvalumab (Imfinzi) + FLOT → durvalumab AstraZeneca Resectable gastric/GEJ adenocarcinoma Traditional approval Trials Reference
8 2025-11-21 Pembrolizumab (Keytruda/Keytruda Qlex) + enfortumab vedotin (Padcev) Merck; Astellas Pharma Neoadjuvant + adjuvant for MIBC (cisplatin-ineligible) Traditional approval Trials Reference
9 2025-11-19 Tarlatamab-dlle (Imdelltra) Amgen Inc. ES-SCLC after platinum chemotherapy Traditional approval Trials Reference
10 2025-11-19 Sevabertinib (Hyrnuo) Bayer HealthCare Pharmaceuticals Inc. HER2 (ERBB2) TKD–mutated non-squamous NSCLC after prior therapy Accelerated approval Trials Reference
11 2025-11-19 Daratumumab + hyaluronidase-fihj (Darzalex Faspro) + VCd Janssen Biotech Inc. Newly diagnosed AL amyloidosis Traditional approval Trials Reference
12 2025-11-19 Selumetinib (KOSELUGO) AstraZeneca Pharmaceuticals LP Adults with NF1 + symptomatic inoperable PN Traditional approval Trials Reference
13 2025-11-18 Epcoritamab-bysp (Epkinly) Genmab US, Inc. Follicular lymphoma indications (combo + mono) Traditional approval Trials Reference
14 2025-11-13 Pertuzumab-dpzb (Poherdy) — interchangeable biosimilar to Perjeta Shanghai Henlius Biologics Co. Ltd. Interchangeable biosimilar to pertuzumab Traditional approval Trials Reference
15 2025-11-13 Ziftomenib (Komzifti) Kura Oncology, Inc. R/R AML with susceptible NPM1 mutation (no satisfactory alternatives) Traditional approval Trials Reference
16 2025-11-06 Daratumumab + hyaluronidase-fihj (Darzalex Faspro) Janssen Biotech, Inc. High-risk smoldering multiple myeloma Traditional approval Trials Reference
17 2025-10-24 Revumenib (Revuforj) Syndax Pharmaceuticals, Inc. R/R AML with susceptible NPM1 mutation Traditional approval Trials Reference
18 2025-10-23 Belantamab mafodotin-blmf (Blenrep) + bortezomib + dexamethasone GlaxoSmithKline R/R multiple myeloma after ≥2 prior lines Traditional approval Trials Reference
19 2025-10-08 Cemiplimab-rwlc (Libtayo) Regeneron Pharmaceuticals Inc. Adjuvant CSCC at high risk of recurrence after surgery + radiation Traditional approval Trials Reference
20 2025-10-02 Lurbinectedin (Zepzelca) + atezolizumab (Tecentriq / Tecentriq Hybreza) Jazz Pharmaceuticals, Inc.; Genentech Inc. Maintenance for ES-SCLC after induction Traditional approval Trials Reference
21 2025-09-25 Imlunestrant (Inluriyo) Eli Lilly and Company ER+, HER2–, ESR1-mutated advanced/metastatic breast cancer after ≥1 endocrine line Traditional approval Trials Reference
22 2025-09-19 Pembrolizumab + berahyaluronidase alfa-pmph (Keytruda Qlex) Merck Subcutaneous injection across approved pembrolizumab solid tumor indications Traditional approval Trials Reference
23 2025-09-10 Selumetinib (KOSELUGO) granules/capsules AstraZeneca Pharmaceuticals LP Pediatric NF1 + symptomatic inoperable PN (≥1 year) Traditional approval Trials Reference
24 2025-09-09 Gemcitabine intravesical system (Inlexzo) Janssen Biotech, Inc. BCG-unresponsive NMIBC with CIS ± papillary tumors Traditional approval Trials Reference
25 2025-08-08 Zongertinib (Hernexeos) Boehringer Ingelheim Pharmaceuticals, Inc. HER2 TKD–mutated non-squamous NSCLC after prior therapy Accelerated approval Trials Reference
26 2025-08-06 Dordaviprone (Modeyso) Jazz Pharmaceuticals, Inc. Diffuse midline glioma (H3 K27M) progressive after therapy Accelerated approval Trials Reference
27 2025-07-02 Sunvozertinib (Zegfrovy) Dizal (Jiangsu) Pharmaceutical Co., Ltd. EGFR exon 20 insertion NSCLC after platinum Accelerated approval Trials Reference
28 2025-06-12 Mitomycin intravesical solution (Zusduri) UroGen Pharma Recurrent low-grade intermediate-risk NMIBC Traditional approval Trials Reference
29 2025-06-11 Taletrectinib (Ibtrozi) Nuvation Bio Inc. ROS1+ locally advanced/metastatic NSCLC Traditional approval Trials Reference
30 2025-06-03 Darolutamide (Nubeqa) Bayer Healthcare Pharmaceuticals Inc. Metastatic castration-sensitive prostate cancer Traditional approval Trials Reference
31 2025-05-15 Retifanlimab-dlwr (Zynyz) + carbo/paclitaxel; also monotherapy Incyte Corporation Squamous cell carcinoma of the anal canal (SCAC) Traditional approval Trials Reference
32 2025-05-14 Telisotuzumab vedotin-tllv (Emrelis) AbbVie Inc. c-Met high overexpression non-squamous NSCLC after prior therapy Accelerated approval Trials Reference
33 2025-05-14 Belzutifan (Welireg) Merck & Co., Inc. Locally advanced/unresectable or metastatic PPGL (≥12 years) Traditional approval Trials Reference
34 2025-05-08 Avutometinib + defactinib (Avmapki Fakzynja co-pack) Verastem, Inc. KRAS-mutated recurrent LGSOC after prior therapy Accelerated approval Trials Reference
35 2025-04-23 Penpulimab-kcqx Akeso Biopharma Co., Ltd. 1L recurrent/metastatic non-keratinizing NPC (with chemo) Traditional approval Trials Reference
36 2025-04-11 Nivolumab (Opdivo) + ipilimumab (Yervoy) Bristol Myers Squibb Company 1L unresectable/metastatic HCC Traditional approval Trials Reference
37 2025-04-08 Nivolumab (Opdivo) + ipilimumab (Yervoy) Bristol Myers Squibb Company Unresectable/metastatic MSI-H/dMMR CRC (≥12 years) Traditional approval Trials Reference
38 2025-03-28 Durvalumab (Imfinzi) + gem/cis → durvalumab AstraZeneca Muscle invasive bladder cancer (perioperative) Traditional approval Trials Reference
39 2025-03-28 Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) — indication expansion Novartis Pharmaceuticals Corporation PSMA+ mCRPC (earlier-line) Traditional approval Trials Reference
40 2025-03-19 Mosunetuzumab-axgb (Lunsumio) Genentech, Inc. FL after ≥2 prior systemic therapies (peds/adults) Traditional approval Trials Reference
41 2025-03-14 Tislelizumab-jsgr (Tevimbra) BeiGene, Ltd. Unresectable/metastatic ESCC (with platinum/fluoropyrimidine) Traditional approval Trials Reference
42 2025-03-11 Nivolumab (Opdivo) + chemo Bristol Myers Squibb Company 1L unresectable/advanced or metastatic gastric/GEJ adenocarcinoma Traditional approval Trials Reference
43 2025-03-11 Pembrolizumab (Keytruda) + lenvatinib (Lenvima) Merck; Eisai Inc. Primary advanced/recurrent endometrial carcinoma Traditional approval Trials Reference
44 2025-03-11 Pembrolizumab (Keytruda) + trastuzumab + chemo Merck; Genentech, Inc. 1L HER2+ unresectable/advanced or metastatic gastric/GEJ adenocarcinoma Traditional approval Trials Reference
45 2025-03-07 Durvalumab (Imfinzi) + chemo AstraZeneca 1L ES-SCLC Traditional approval Trials Reference
46 2025-02-14 Talquetamab-tgvs (Talvey) Janssen Biotech, Inc. R/R multiple myeloma (new dosing schedule) Traditional approval Trials Reference
47 2025-02-13 Tislelizumab-jsgr (Tevimbra) BeiGene, Ltd. 1L metastatic NSCLC (with pemetrexed/platinum) Traditional approval Trials Reference
48 2025-02-12 Brentuximab vedotin (Adcetris) + lenalidomide + rituximab Seagen Inc. (Pfizer) R/R LBCL after ≥2 lines (HSCT/CAR-T ineligible) Traditional approval Trials Reference
49 2025-02-11 Mirdametinib (Gomekli) SpringWorks Therapeutics, Inc. NF1 with symptomatic PN not amenable to resection (≥2 years) Traditional approval Trials Reference
50 2025-02-06 Treosulfan (Grafapex) + fludarabine medac GmbH Preparative regimen for alloHSCT in AML/MDS Traditional approval Trials Reference
51 2025-01-27 Fam-trastuzumab deruxtecan-nxki (Enhertu) Daiichi Sankyo, Inc. HR+ HER2-low/ultralow metastatic breast cancer after endocrine therapy Traditional approval Trials Reference
52 2025-01-17 Datopotamab deruxtecan-dlnk (Datroway) Daiichi Sankyo, Inc. HR+, HER2– metastatic breast cancer after endocrine + chemo Traditional approval Trials Reference
53 2025-01-16 Sotorasib + panitumumab (Lumakras + Vectibix) Amgen Inc. KRAS G12C-mutated mCRC after fluoropyrimidine/oxaliplatin/irinotecan Traditional approval Trials Reference
54 2025-01-16 Acalabrutinib + bendamustine + rituximab (Calquence-based regimen) AstraZeneca Previously untreated mantle cell lymphoma (HSCT-ineligible) Traditional approval Trials Reference
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