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{| class="wikitable sortable"
{| class="wikitable sortable"
|+ FDA Oncology Approvals 2025
! Item Number
! # !! Approval Date !! Medication (Brand) !! Company !! Indication !! Clinical Trial Name
! Approval Date
! Medication (Brand)
! Company
! Indication
! Clinical Trial Name (all trials listed on FDA page)
! FDA Approval Link
|-
|-
| 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib + Panitumumab (Lumakras + Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreaK 300
| 1
| 12/17/2025
| Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro)
| Janssen Biotech, Inc.
| Subcutaneous injection across all indications approved for IV amivantamab (Rybrevant)
| PALOMA-3
| https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection
|-
|-
| 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib + Bendamustine + Rituximab (Calquence)] || AstraZeneca || Previously untreated mantle cell lymphoma || ELEVATE-TN
| 2
| 12/17/2025
| Rucaparib (Rubraca)
| pharmaand GmbH
| Adults with deleterious BRCA mutation–associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy
| TRITON3 (NCT02975934)
| https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer
|-
|-
| 3 || 2025-01-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-unresectable-or-metastatic-breast-cancer Datopotamab deruxtecan-dlnk (Datroway)] || Daiichi Sankyo || HR-positive, HER2-negative metastatic breast cancer || TROPION-Breast01
| 5
| 12/4/2025
| Lisocabtagene maraleucel (Breyanzi)
| Juno Therapeutics, Inc. (a Bristol-Myers Squibb Company)
| Adults with relapsed or refractory marginal zone lymphoma after ≥2 prior lines of systemic therapy
| TRANSCEND FL-MZL Cohort (NCT04245839)
| https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma
|-
|-
| 4 || 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan + Fludarabine (Grafapex)] || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L
| 7
| 11/25/2025
| Durvalumab (Imfinzi)
| AstraZeneca
| With FLOT chemotherapy as neoadjuvant/adjuvant treatment, followed by single-agent durvalumab, for resectable gastric or gastroesophageal junction adenocarcinoma
| MATTERHORN (NCT04592913)
| https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma
|-
|-
| 5 || 2025-01-25 || [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 || EPCORE NHL-1
| 8
| 11/21/2025
| Pembrolizumab (Keytruda) / pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) + enfortumab vedotin-ejfv (Padcev)
| Merck / Astellas Pharma
| Neoadjuvant followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer who are ineligible for cisplatin
| KEYNOTE-905/EV-303 (NCT03924895)
| https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer
|-
|-
| 6 || 2025-01-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia Ziftomenib (Komzifti)] || Kura Oncology || R/R AML with NPM1 mutation || KOMET-001
| 9
| 11/19/2025
| Tarlatamab-dlle (Imdelltra)
| Amgen Inc.
| Adults with extensive stage small cell lung cancer with progression on or after platinum-based chemotherapy
| DeLLphi-304 (NCT05740566)
| https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer
|-
|-
| 7 || 2025-02-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu
| 10
| 11/19/2025
| Sevabertinib (Hyrnuo)
| Bayer HealthCare Pharmaceuticals Inc.
| Adults with locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations after prior systemic therapy
| SOHO-01 (NCT05099172)
| https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer
|-
|-
| 8 || 2025-02-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor || MOTION
| 13
|-
| 11/18/2025
| 9 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-unresectable-or-metastatic-pleural-mesothelioma Pembrolizumab (Keytruda)] || Merck || First-line unresectable pleural mesothelioma || IND.227
| Epcoritamab-bysp (Epkinly) + lenalidomide + rituximab; and Epkinly monotherapy
|-
| Genmab US, Inc.
| 10 || 2025-02-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-neoadjuvant-and-adjuvant-treatment-resectable-non-small-cell-lung-cancer Durvalumab (Imfinzi)] || AstraZeneca || Resectable non-small cell lung cancer || AEGEAN
| Follicular lymphoma indications (combo and monotherapy)
|-
| EPCORE FL-1 (Study M20-638; NCT05409066)
| 11 || 2025-03-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanubrutinib-combination-obinutuzumab-relapsed-or-refractory-follicular-lymphoma Zanubrutinib (Brukinsa)] || BeiGene || R/R follicular lymphoma with obinutuzumab || ROSEWOOD
| https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications
|-
| 12 || 2025-03-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-cisplatin-and-gemcitabine-first-line-treatment-unresectable-or-metastatic Nivolumab (Opdivo)] || BMS || First-line metastatic urothelial carcinoma || CheckMate -901
|-
| 13 || 2025-03-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirvetuximab-soravtansine-gynx-fr-alpha-positive-platinum-resistant-epithelial-ovarian Mirvetuximab soravtansine-gynx (Elahere)] || ImmunoGen || FRα-positive platinum-resistant ovarian cancer || MIRASOL
|-
| 14 || 2025-03-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ponatinib-chemotherapy-newly-diagnosed-philadelphia-chromosome-positive-acute Ponatinib (Iclusig)] || Takeda || Newly diagnosed Ph+ ALL || PhALLCON
|-
| 15 || 2025-04-02 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tislelizumab-jsgr-unresectable-or-metastatic-esophageal-squamous-cell-carcinoma Tislelizumab-jsgr (Tevimbra)] || BeiGene || Metastatic esophageal squamous cell carcinoma || RATIONALE-302
|-
| 16 || 2025-04-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-idecabtagene-vicleucel-relapsed-or-refractory-multiple-myeloma-0 Idecabtagene vicleucel (Abecma)] || BMS || Relapsed/refractory multiple myeloma (earlier line) || KarMMa-3
|-
| 17 || 2025-04-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma Ciltacabtagene autoleucel (Carvykti)] || Janssen || R/R multiple myeloma after one prior line || CARTITUDE-4
|-
| 18 || 2025-04-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2-low-or-her2-ultralow Fam-trastuzumab deruxtecan-nxki (Enhertu)] || Daiichi Sankyo || HER2-low or HER2-ultralow metastatic breast cancer || DESTINY-Breast06
|-
| 19 || 2025-04-23 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutathera-pediatric-patients-12-years-and-older-gep-nets Lutathera] || Novartis || Pediatric patients with GEP-NETs || NETTER-P
|-
| 20 || 2025-04-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer Tisotumab vedotin-tftv (Tivdak)] || Seagen || Recurrent or metastatic cervical cancer || innovaTV 301
|-
| 21 || 2025-05-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-pediatric-patients-two-years-and-older-ret-altered-metastatic-medullary Selpercatinib (Retevmo)] || Eli Lilly || Pediatric RET-altered medullary thyroid cancer || LIBRETTO-121
|-
| 22 || 2025-05-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tivozanib-combination-nivolumab-relapsed-or-refractory-renal-cell-carcinoma Tivozanib (Fotivda)] || AVEO || R/R renal cell carcinoma with nivolumab || TiNivo-2
|-
| 23 || 2025-05-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-chemotherapy-non-small-cell-lung-cancer-ex20ins-mutations Amivantamab-vmjw (Rybrevant)] || Janssen || NSCLC with EGFR Exon 20 insertion mutations || PAPILLON
|-
| 24 || 2025-05-30 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma Lisocabtagene maraleucel (Breyanzi)] || BMS || Relapsed or refractory mantle cell lymphoma || TRANSCEND MCL
|-
| 25 || 2025-06-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selinexor-combination-pembrolizumab-recurrent-or-metastatic-endometrial-cancer Selinexor (Xpovio)] || Karyopharm || Recurrent or metastatic endometrial cancer || SIENDO
|-
| 26 || 2025-06-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-blinatumomab-cd19-positive-b-cell-precursor-acute-lymphoblastic-leukemia Blinatumomab (Blincyto)] || Amgen || CD19-positive B-cell precursor ALL || E1910
|-
| 27 || 2025-06-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-adagrasib-combination-cetuximab-kras-g12c-mutated-colorectal-cancer Adagrasib (Krazati)] || BMS || KRAS G12C-mutated colorectal cancer || KRYSTAL-1
|-
| 28 || 2025-06-27 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-chemotherapy-endometrial-cancer Durvalumab (Imfinzi)] || AstraZeneca || dMMR advanced or recurrent endometrial cancer || DUO-E
|-
| 29 || 2025-07-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-chemotherapy-endometrial-cancer Pembrolizumab (Keytruda)] || Merck || Primary advanced or recurrent endometrial cancer || KEYNOTE-868
|-
| 30 || 2025-07-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b-cell-lymphoma Epcoritamab-bysp (Epkinly)] || Genmab || R/R DLBCL after failure of CAR-T || EPCORE NHL-1
|-
| 31 || 2025-07-18 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-advanced-renal-cell-carcinoma Belzutifan (Welireg)] || Merck || Advanced renal cell carcinoma || LITESPARK-005
|-
| 32 || 2025-07-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vorasidenib-grade-2-astrocytoma-or-oligodendroglioma Vorasidenib (Voranigo)] || Servier || Grade 2 astrocytoma or oligodendroglioma || INDIGO
|-
| 33 || 2025-08-01 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-hyaluronidase-fihj-combination-bortezomib-lenalidomide-and-dexamethasone Daratumumab + Hyaluronidase (Darzalex Faspro)] || Janssen || Newly diagnosed multiple myeloma (transplant-eligible) || PERSEUS
|-
| 34 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-afatinib-pediatric-patients-six-years-and-older-advanced-solid-tumors Afatinib (Gilotrif)] || Boehringer Ingelheim || Pediatric advanced solid tumors with ErbB mutations || Study 1200.120
|-
| 35 || 2025-08-15 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-relapsed-or-refractory-indolent-non-hodgkin-lymphoma Axicabtagene ciloleucel (Yescarta)] || Kite || R/R indolent Non-Hodgkin Lymphoma || ZUMA-5
|-
| 36 || 2025-08-22 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-combination-amivantamab-vmjw-first-line-treatment-locally-advanced Lazertinib (Leclaza)] || Janssen || First-line EGFR-mutated NSCLC || MARIPOSA
|-
| 37 || 2025-08-29 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-Inotuzumab-ozogamicin-pediatric-patients-one-year-and-older-relapsed-or-refractory Inotuzumab ozogamicin (Besponsa)] || Pfizer || Pediatric R/R B-cell precursor ALL || Study B1931022
|-
| 38 || 2025-09-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-pemetrexed-and-platinum-chemotherapy-first-line-treatment Pembrolizumab (Keytruda)] || Merck || First-line malignant pleural mesothelioma || KEYNOTE-483
|-
| 39 || 2025-09-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-resected-esophageal-or-gastroesophageal-junction-cancer Nivolumab (Opdivo)] || BMS || Adjuvant resected ESCC || CheckMate -577
|-
| 40 || 2025-09-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanubrutinib-combination-venetoclax-previously-untreated-chronic-lymphocytic-leukemia Zanubrutinib (Brukinsa)] || BeiGene || Untreated CLL/SLL with venetoclax || SEQUOIA
|-
| 41 || 2025-09-26 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive-non-small-cell-lung Selpercatinib (Retevmo)] || Eli Lilly || RET fusion-positive NSCLC || LIBRETTO-431
|-
| 42 || 2025-10-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-entrectinib-pediatric-patients-older-one-month-ntrk-fusion-positive-solid-tumors Entrectinib (Rozlytrek)] || Genentech || Pediatric NTRK fusion-positive solid tumors || STARTRK-NG
|-
| 43 || 2025-10-10 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-trametinib-combination-dabrafenib-pediatric-patients-low-grade-glioma Trametinib (Mekinist)] || Novartis || Pediatric low-grade glioma with BRAF V600E || Study G2201
|-
| 44 || 2025-10-17 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-gemcitabine-and-cisplatin-locally-advanced-or-metastatic Pembrolizumab (Keytruda)] || Merck || Advanced or metastatic biliary tract cancer || KEYNOTE-966
|-
| 45 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-doxorubicin-relapsed-small-cell-lung-cancer Lurbinectedin (Zepzelca)] || Jazz Pharma || Relapsed small cell lung cancer || LAGOON
|-
| 46 || 2025-10-31 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fruquintinib-previously-treated-metastatic-colorectal-cancer Fruquintinib (Fruzaqla)] || Takeda || Refractory metastatic colorectal cancer || FRESCO-2
|-
| 47 || 2025-11-07 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-combination-fulvestrant-advanced-hr-positive-her2-negative-breast-cancer Capivasertib (Truqap)] || AstraZeneca || HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alterations || CAPItello-291
|-
| 48 || 2025-11-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-repotrectinib-locally-advanced-or-metastatic-ros1-positive-non-small-cell-lung-cancer Repotrectinib (Augtyro)] || BMS || ROS1-positive metastatic NSCLC || TRIDENT-1
|-
| 49 || 2025-11-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nirogacestat-adult-patients-progressing-desmoid-tumors Nirogacestat (Ogsiveo)] || SpringWorks || Progressing desmoid tumors || DeFi
|-
| 50 || 2025-11-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-chemotherapy-neoadjuvant-and-adjuvant-treatment-resectable Durvalumab (Imfinzi)] || AstraZeneca || Resectable NSCLC (perioperative) || AEGEAN
|-
| 51 || 2025-12-05 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pirtobrutinib-relapsed-or-refractory-chronic-lymphocytic-leukemia-or-small Pirtobrutinib (Jaypirca)] || Eli Lilly || R/R CLL/SLL after BTK and BCL-2 inhibitors || BRUIN
|-
| 52 || 2025-12-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzumig-advanced-clear-cell-renal-cell-carcinoma Belzutifan (Welireg)] || Merck || Advanced clear cell renal cell carcinoma || LITESPARK-005
|-
| 53 || 2025-12-19 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tivozanib-combination-nivolumab-second-line-renal-cell-carcinoma Tivozanib (Fotivda)] || AVEO || Second-line renal cell carcinoma || TiNivo-2
|-
| 54 || 2025-12-28 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-combination-chemotherapy-first-line-advanced-gastric-cancer Pembrolizumab (Keytruda)] || Merck || First-line HER2-negative gastric cancer || KEYNOTE-859
|}
|}

Revision as of 23:16, 31 December 2025

Item Number Approval Date Medication (Brand) Company Indication Clinical Trial Name (all trials listed on FDA page) FDA Approval Link
1 12/17/2025 Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) Janssen Biotech, Inc. Subcutaneous injection across all indications approved for IV amivantamab (Rybrevant) PALOMA-3 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection
2 12/17/2025 Rucaparib (Rubraca) pharmaand GmbH Adults with deleterious BRCA mutation–associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy TRITON3 (NCT02975934) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer
5 12/4/2025 Lisocabtagene maraleucel (Breyanzi) Juno Therapeutics, Inc. (a Bristol-Myers Squibb Company) Adults with relapsed or refractory marginal zone lymphoma after ≥2 prior lines of systemic therapy TRANSCEND FL-MZL Cohort (NCT04245839) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma
7 11/25/2025 Durvalumab (Imfinzi) AstraZeneca With FLOT chemotherapy as neoadjuvant/adjuvant treatment, followed by single-agent durvalumab, for resectable gastric or gastroesophageal junction adenocarcinoma MATTERHORN (NCT04592913) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma
8 11/21/2025 Pembrolizumab (Keytruda) / pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) + enfortumab vedotin-ejfv (Padcev) Merck / Astellas Pharma Neoadjuvant followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer who are ineligible for cisplatin KEYNOTE-905/EV-303 (NCT03924895) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer
9 11/19/2025 Tarlatamab-dlle (Imdelltra) Amgen Inc. Adults with extensive stage small cell lung cancer with progression on or after platinum-based chemotherapy DeLLphi-304 (NCT05740566) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer
10 11/19/2025 Sevabertinib (Hyrnuo) Bayer HealthCare Pharmaceuticals Inc. Adults with locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations after prior systemic therapy SOHO-01 (NCT05099172) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer
13 11/18/2025 Epcoritamab-bysp (Epkinly) + lenalidomide + rituximab; and Epkinly monotherapy Genmab US, Inc. Follicular lymphoma indications (combo and monotherapy) EPCORE FL-1 (Study M20-638; NCT05409066) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications
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