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{| class="wikitable sortable" style="width:100%;"
{| class="wikitable sortable"
! #
|+ FDA Oncology Approvals & Major Label Updates 2025
! Approval date
! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name
! Medication (Brand)
! Company
! Indication
! Regulatory type
 
|-
|-
| 1 | 12/17/2025 | Amivantamab + hyaluronidase-lpuj (Rybrevant Faspro) | Janssen Biotech, Inc. | Subcutaneous injection across all approved amivantamab indications | Traditional
| 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
|-
|-
| 2 | 12/17/2025 | Rucaparib (Rubraca) | pharmaand GmbH | BRCA-mutated mCRPC after androgen receptor therapy | Traditional
| 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
|-
|-
| 3 | 12/15/2025 | Fam-trastuzumab deruxtecan-nxki + pertuzumab (Enhertu + Perjeta) | Daiichi Sankyo | 1L unresectable/metastatic HER2+ breast cancer | Traditional
| 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
|-
|-
| 4 | 12/12/2025 | Niraparib + abiraterone acetate + prednisone (Akeega) | Janssen Biotech | BRCA2-mutated mCSPC | Traditional
| 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
|-
|-
| 5 | 12/04/2025 | Lisocabtagene maraleucel (Breyanzi) | Juno / BMS | R/R marginal zone lymphoma ≥2 lines | Traditional
| 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
|-
|-
| 6 | 12/03/2025 | Pirtobrutinib (Jaypirca) | Eli Lilly | R/R CLL/SLL after BTK inhibitor | Traditional
| 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
|-
|-
| 7 | 11/25/2025 | Durvalumab (Imfinzi) | AstraZeneca | Resectable gastric/GEJ adenocarcinoma | Traditional
| 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
|-
|-
| 8 | 11/21/2025 | Pembrolizumab + enfortumab vedotin (Keytruda + Padcev) | Merck / Astellas | Cisplatin-ineligible MIBC | Traditional
| 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
|-
|-
| 9 | 11/19/2025 | Tarlatamab-dlle (Imdelltra) | Amgen | ES-SCLC after platinum | Traditional
| 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
|-
|-
| 10 | 11/19/2025 | Sevabertinib (Hyrnuo) | Bayer | HER2-mutated NSCLC | Accelerated
| 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
|-
|-
| 11 | 11/19/2025 | Daratumumab + hyaluronidase-fihj (Darzalex Faspro) | Janssen | Newly diagnosed AL amyloidosis | Traditional
| 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
|-
|-
| 12 | 11/19/2025 | Selumetinib (KOSELUGO) | AstraZeneca | Adult NF1 plexiform neurofibromas | Traditional
| 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
|-
|-
| 13 | 11/18/2025 | Epcoritamab-bysp (Epkinly) | Genmab | Relapsed/refractory follicular lymphoma | Traditional
| 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
|-
|-
| 14 | 11/13/2025 | Pertuzumab-dpzb (Poherdy) | Henlius | Interchangeable biosimilar to Perjeta | Traditional
| 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
|-
|-
| 15 | 11/13/2025 | Ziftomenib (Komzifti) | Kura Oncology | R/R NPM1-mutated AML | Traditional
| 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
|-
|-
| 16 | 11/06/2025 | Daratumumab + hyaluronidase-fihj | Janssen | High-risk smoldering multiple myeloma | Traditional
| 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
|-
|-
| 17 | 10/24/2025 | Revumenib (Revuforj) | Syndax | R/R NPM1-mutated AML | Traditional
| 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
|-
|-
| 18 | 10/23/2025 | Belantamab mafodotin-blmf (Blenrep) | GSK | R/R multiple myeloma ≥2 lines | Traditional
| 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
|-
|-
| 19 | 10/08/2025 | Cemiplimab-rwlc (Libtayo) | Regeneron | Adjuvant CSCC | Traditional
| 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
|-
|-
| 20 | 10/02/2025 | Lurbinectedin + atezolizumab | Jazz / Genentech | ES-SCLC maintenance | Traditional
| 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
|-
|-
| 21 | 09/25/2025 | Imlunestrant (Inluriyo) | Eli Lilly | ESR1-mutated ER+ MBC | Traditional
| 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
|-
|-
| 22 | 09/19/2025 | Pembrolizumab SC (Keytruda Qlex) | Merck | Solid tumors (SC formulation) | Traditional
| 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
|-
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| 23 | 09/10/2025 | Selumetinib (KOSELUGO) | AstraZeneca | Pediatric NF1 PN | Traditional
| 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
|-
|-
| 24 | 09/09/2025 | Gemcitabine intravesical system (Inlexzo) | Janssen | BCG-unresponsive NMIBC | Traditional
| 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
|-
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| 25 | 08/08/2025 | Zongertinib (Hernexeos) | Boehringer Ingelheim | HER2-mutated NSCLC | Accelerated
| 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
|-
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| 26 | 08/06/2025 | Dordaviprone (Modeyso) | Jazz | Diffuse midline glioma | Accelerated
| 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
|-
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| 27 | 07/02/2025 | Sunvozertinib (Zegfrovy) | Dizal | EGFR exon 20 NSCLC | Accelerated
| 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
|-
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| 28 | 07/02/2025 | Linvoseltamab-gcpt (Lynozyfic) | Regeneron | R/R multiple myeloma | Accelerated
| 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)
|-
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| 29 | 06/23/2025 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | EGFR-mutated NSCLC | Accelerated
| 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
|-
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| 30 | 06/18/2025 | Tafasitamab-cxix (Monjuvi) | Incyte | R/R follicular lymphoma | Traditional
| 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
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| 31 | 06/12/2025 | Pembrolizumab (Keytruda) | Merck | Resectable HNSCC | Traditional
| 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
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| 32 | 06/12/2025 | Mitomycin intravesical solution (Zusduri) | UroGen | LG-IR NMIBC | Traditional
| 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
|-
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| 33 | 06/11/2025 | Taletrectinib (Ibtrozi) | Nuvation Bio | ROS1+ NSCLC | Traditional
| 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
|-
|-
| 34 | 06/03/2025 | Darolutamide (Nubeqa) | Bayer | mCSPC | Traditional
| 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
|-
|-
| 35 | 05/15/2025 | Retifanlimab-dlwr (Zynyz) | Incyte | Anal squamous cell carcinoma | Traditional
| 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
|-
|-
| 36 | 05/14/2025 | Telisotuzumab vedotin-tllv (Emrelis) | AbbVie | c-MET high NSCLC | Accelerated
| 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
|-
|-
| 37 | 05/14/2025 | Belzutifan (Welireg) | Merck | PPGL | Traditional
| 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
|-
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| 38 | 05/08/2025 | Avutometinib + defactinib | Verastem | KRAS-mutated LGSOC | Accelerated
| 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
|-
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| 39 | 04/23/2025 | Penpulimab-kcqx | Akeso | Nasopharyngeal carcinoma | Traditional
| 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
|-
|-
| 40 | 04/11/2025 | Nivolumab + ipilimumab | BMS | HCC | Traditional
| 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
|-
|-
| 41 | 04/08/2025 | Nivolumab + ipilimumab | BMS | MSI-H/dMMR CRC | Traditional
| 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
|-
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| 42 | 03/28/2025 | Durvalumab | AstraZeneca | MIBC | Traditional
| 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
|-
|-
| 43 | 03/28/2025 | Lutetium Lu-177 vipivotide tetraxetan (Pluvicto) | Novartis | PSMA+ mCRPC | Traditional
| 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
|-
|-
| 44 | 03/26/2025 | Cabozantinib (Cabometyx) | Exelixis | pNET / epNET | Traditional
| 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
|-
|-
| 45 | 03/19/2025 | Pembrolizumab + trastuzumab | Merck | HER2+ gastric cancer | Traditional
| 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
|-
|-
| 46 | 02/14/2025 | Vimseltinib (Romvimza) | Deciphera | TGCT | Traditional
| 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
|-
|-
| 47 | 02/12/2025 | Brentuximab vedotin + lenalidomide + rituximab | Seagen | R/R LBCL | Traditional
| 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
|-
|-
| 48 | 02/11/2025 | Mirdametinib (Gomekli) | SpringWorks | NF1 plexiform neurofibromas | Traditional
| 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
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| 49 | 02/06/2025 | Treosulfan + fludarabine | medac | AML/MDS HSCT conditioning | Traditional
| 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
|-
|-
| 50 | 01/27/2025 | Fam-trastuzumab deruxtecan-nxki (Enhertu) | Daiichi Sankyo | HR+ HER2-low breast cancer | Traditional
| 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
|-
|-
| 51 | 01/17/2025 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | HR+ HER2- breast cancer | Traditional
| 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
|-
|-
| 52 | 01/16/2025 | Sotorasib + panitumumab | Amgen | KRAS G12C mCRC | Traditional
| 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
|-
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| 53 | 01/16/2025 | Acalabrutinib + bendamustine + rituximab | AstraZeneca | Untreated mantle cell lymphoma | Traditional
| 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
|}
|}

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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