FDA Oncology Approvals 2025: Difference between revisions
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{| class="wikitable sortable" |+ FDA Oncology Approvals & Major Label Updates 2025 ! # !! Approval Date !! Medication (Brand Name) !! Indication !! Clinical Trial Name |- | 1 || 2025-01-16 || | {| class="wikitable sortable" | ||
|+ FDA Oncology Approvals & Major Label Updates 2025 | |||
! # !! Approval Date !! Medication (Brand Name) !! Company !! Indication !! Clinical Trial Name | |||
|- | |||
| 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 || 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 | |||
|- | |||
| 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 || 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 | |||
|- | |||
| 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 | |||
|- | |||
| 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 | |||
|- | |||
| 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 | |||
|- | |||
| 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) | |||
|- | |||
| 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 | |||
|- | |||
| 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 | |||
|- | |||
| 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 | |||
|- | |||
| 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 | |||
|- | |||
| 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 || 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 || 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 || 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 || 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 | |||
|- | |||
| 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 | |||
|- | |||
| 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 || 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 || 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 | |||
|- | |||
| 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 || 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 || 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 || 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 || 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 || 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 || 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 | |||
|- | |||
| 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 || 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 || 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 || 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 | |||
|- | |||
| 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
| # | 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 |