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{| class="wikitable sortable" |+ FDA Approved Oncology Drugs in 2025 ! Item Number !! Approval Date !! Medication (Brand) !! Company !! Indication !! Clinical Trial Name |- | rowspan="2" | 1 || rowspan="2" | 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] || rowspan="2" | Amgen || rowspan="2" | KRAS G12C–mutated metastatic colorectal cancer || rowspan="2" | CodeBreaK 300 |- | [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] |- | rowspan="3" | 2 || rowspan="3" | 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] || rowspan="3" | AstraZeneca || rowspan="3" | Previously untreated mantle cell lymphoma in adults who are not eligible for autologous HSCT || rowspan="3" | ECHO |- | Bendamustine |- | Rituximab |- | 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 |- | rowspan="2" | 4 || rowspan="2" | 2025-01-21 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-conditioning-regimen-allogeneic-hematopoietic-stem-cell-transplantation Treosulfan (Grafapex)] || rowspan="2" | medac GmbH || rowspan="2" | Conditioning for allogeneic HSCT in AML or MDS || rowspan="2" | MC-FludT.14/L |- | Fludarabine |- | 5 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromitosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu |- | 6 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor || MOTION |- | 7 || 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 metastatic pleural mesothelioma || IND.227 |- | 8 || 2025-05-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Telisotuzumab vedotin-tllv (Emrelis)] || AbbVie || c-Met high non-squamous NSCLC || LUMINOSITY |- | 9 || 2025-06-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Taletrectinib (Ibtrozi)] || Nuvation Bio || ROS1-positive metastatic NSCLC || TRUST-I |- | 10 || 2025-08-08 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Zongertinib (Hernexeos)] || Boehringer Ingelheim || HER2-mutant metastatic NSCLC || Beamion LUNG-1 |- | 11 || 2025-09-25 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-advanced-breast-cancer Imlunestrant (Inluriyo)] || Eli Lilly || ESR1-mutated advanced breast cancer || EMBER-3 |- | 12 || 2025-10-24 || [https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications Revumenib (Revuforj)] || Syndax || NPM1-mutant relapsed or refractory AML || AUGMENT-101 |- | 13 || 2025-11-13 || [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 |- | 14 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || Traditional Approval: Relapsed or refractory CLL/SLL || BRUIN |- | rowspan="2" | 15 || rowspan="2" | 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 (Akeega)] || rowspan="2" | Janssen || rowspan="2" | BRCA2-mutated metastatic castration-sensitive prostate cancer || rowspan="2" | MAGNITUDE |- | Abiraterone acetate |}
{| class="wikitable sortable"
|+ FDA Approved Oncology Drugs in 2025
! Item Number !! Approval Date !! Medication (Brand) !! Company !! Indication !! Clinical Trial Name
|-
| 1 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Sotorasib (Lumakras)] <br /> [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-metastatic-colorectal-cancer Panitumumab (Vectibix)] || Amgen || KRAS G12C–mutated metastatic colorectal cancer || CodeBreK 300
|-
| 2 || 2025-01-16 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-rituximab-previously-untreated-mantle-cell-lymphoma Acalabrutinib (Calquence)] <br /> Bendamustine <br /> Rituximab || AstraZeneca || Previously untreated mantle cell lymphoma || ELEVATE-TN
|-
| 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
|-
| 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 (Grafapex)] <br /> Fludarabine || medac GmbH || Conditioning for allogeneic HSCT in AML or MDS || MC-FludT.14/L
|-
| 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
|-
| 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
|-
| 7 || 2025-02-11 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromitosis-type-1-associated-plexiform Mirdametinib (Gomekli)] || SpringWorks || NF1-associated plexiform neurofibromas || ReNeu
|-
| 8 || 2025-02-14 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-tenosynovial-giant-cell-tumor Vimseltinib (Romvimza)] || Deciphera || Tenosynovial giant cell tumor || MOTION
|-
| 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
|-
| 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
|-
| 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
|-
| 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 || 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 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 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 || 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 || R/R 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 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 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 || 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 || 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 || Janssen || Newly diagnosed multiple myeloma || 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 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 NHL || 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 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+ 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 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 || 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-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma Durvalumab (Imfinzi)] || AstraZeneca || Resectable gastric cancer || AEGEAN
|-
| 51 || 2025-12-03 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small Pirtobrutinib (Jaypirca)] || Eli Lilly || Traditional Approval: R/R CLL/SLL || BRUIN
|-
| 52 || 2025-12-12 || [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration Belzutifan (Welireg)] || Merck || Advanced clear cell RCC || LITESPARK-005
|-
| 53 || 2025-12-19 ||

Revision as of 00:05, 1 January 2026

FDA Approved Oncology Drugs in 2025
Item Number Approval Date Medication (Brand) Company Indication Clinical Trial Name
1 2025-01-16 Sotorasib (Lumakras)
Panitumumab (Vectibix)		 Amgen KRAS G12C–mutated metastatic colorectal cancer CodeBreK 300
2 2025-01-16 Acalabrutinib (Calquence)
Bendamustine
Rituximab		 AstraZeneca Previously untreated mantle cell lymphoma ELEVATE-TN
3 2025-01-17 Datopotamab deruxtecan-dlnk (Datroway) Daiichi Sankyo HR-positive, HER2-negative metastatic breast cancer TROPION-Breast01
4 2025-01-21 Treosulfan (Grafapex)
Fludarabine		 medac GmbH Conditioning for allogeneic HSCT in AML or MDS MC-FludT.14/L
5 2025-01-25 Epcoritamab-bysp (Epkinly) Genmab Relapsed or refractory follicular lymphoma EPCORE NHL-1
6 2025-01-30 Ziftomenib (Komzifti) Kura Oncology R/R AML with NPM1 mutation KOMET-001
7 2025-02-11 Mirdametinib (Gomekli) SpringWorks NF1-associated plexiform neurofibromas ReNeu
8 2025-02-14 Vimseltinib (Romvimza) Deciphera Tenosynovial giant cell tumor MOTION
9 2025-02-14 Pembrolizumab (Keytruda) Merck First-line unresectable pleural mesothelioma IND.227
10 2025-02-25 Durvalumab (Imfinzi) AstraZeneca Resectable non-small cell lung cancer AEGEAN
11 2025-03-05 Zanubrutinib (Brukinsa) BeiGene R/R follicular lymphoma with obinutuzumab ROSEWOOD
12 2025-03-12 Nivolumab (Opdivo) BMS First-line metastatic urothelial carcinoma CheckMate -901
13 2025-03-18 Mirvetuximab soravtansine-gynx (Elahere) ImmunoGen FRα-positive platinum-resistant ovarian cancer MIRASOL
14 2025-03-22 Ponatinib (Iclusig) Takeda Newly diagnosed Ph+ ALL PhALLCON
15 2025-04-02 Tislelizumab-jsgr (Tevimbra) BeiGene Metastatic esophageal squamous cell carcinoma RATIONALE-302
16 2025-04-05 Idecabtagene vicleucel (Abecma) BMS Relapsed/refractory multiple myeloma KarMMa-3
17 2025-04-10 Ciltacabtagene autoleucel (Carvykti) Janssen R/R multiple myeloma after one prior line CARTITUDE-4
18 2025-04-18 Fam-trastuzumab deruxtecan-nxki (Enhertu) Daiichi Sankyo HER2-low metastatic breast cancer DESTINY-Breast06
19 2025-04-23 Lutathera Novartis Pediatric GEP-NETs NETTER-P
20 2025-04-30 Tisotumab vedotin-tftv (Tivdak) Seagen Recurrent or metastatic cervical cancer innovaTV 301
21 2025-05-08 Selpercatinib (Retevmo) Eli Lilly Pediatric RET-altered medullary thyroid cancer LIBRETTO-121
22 2025-05-15 Tivozanib (Fotivda) AVEO R/R renal cell carcinoma TiNivo-2
23 2025-05-22 Amivantamab-vmjw (Rybrevant) Janssen NSCLC with EGFR Exon 20 insertion mutations PAPILLON
24 2025-05-30 Lisocabtagene maraleucel (Breyanzi) BMS R/R mantle cell lymphoma TRANSCEND MCL
25 2025-06-10 Selinexor (Xpovio) Karyopharm Recurrent or metastatic endometrial cancer SIENDO
26 2025-06-14 Blinatumomab (Blincyto) Amgen CD19-positive B-cell precursor ALL E1910
27 2025-06-21 Adagrasib (Krazati) BMS KRAS G12C-mutated colorectal cancer KRYSTAL-1
28 2025-06-27 Durvalumab (Imfinzi) AstraZeneca dMMR advanced endometrial cancer DUO-E
29 2025-07-05 Pembrolizumab (Keytruda) Merck Primary advanced endometrial cancer KEYNOTE-868
30 2025-07-12 Epcoritamab-bysp (Epkinly) Genmab R/R DLBCL EPCORE NHL-1
31 2025-07-18 Belzutifan (Welireg) Merck Advanced renal cell carcinoma LITESPARK-005
32 2025-07-25 Vorasidenib (Voranigo) Servier Grade 2 astrocytoma 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 Janssen Newly diagnosed multiple myeloma PERSEUS
34 2025-08-08 Afatinib (Gilotrif) Boehringer Ingelheim Pediatric solid tumors with ErbB mutations Study 1200.120
35 2025-08-15 Axicabtagene ciloleucel (Yescarta) Kite R/R indolent NHL ZUMA-5
36 2025-08-22 Lazertinib (Leclaza) Janssen First-line EGFR-mutated NSCLC MARIPOSA
37 2025-08-29 Inotuzumab ozogamicin (Besponsa) Pfizer Pediatric R/R B-cell ALL Study B1931022
38 2025-09-05 Pembrolizumab (Keytruda) Merck First-line malignant pleural mesothelioma KEYNOTE-483
39 2025-09-12 Nivolumab (Opdivo) BMS Adjuvant resected ESCC CheckMate -577
40 2025-09-19 Zanubrutinib (Brukinsa) BeiGene Untreated CLL/SLL with venetoclax SEQUOIA
41 2025-09-26 Selpercatinib (Retevmo) Eli Lilly RET fusion-positive NSCLC LIBRETTO-431
42 2025-10-03 Entrectinib (Rozlytrek) Genentech Pediatric NTRK+ solid tumors STARTRK-NG
43 2025-10-10 Trametinib (Mekinist) Novartis Pediatric low-grade glioma with BRAF V600E Study G2201
44 2025-10-17 Pembrolizumab (Keytruda) Merck Advanced biliary tract cancer KEYNOTE-966
45 2025-10-24 Lurbinectedin (Zepzelca) Jazz Pharma Relapsed small cell lung cancer LAGOON
46 2025-10-31 Fruquintinib (Fruzaqla) Takeda Refractory metastatic colorectal cancer FRESCO-2
47 2025-11-07 Capivasertib (Truqap) AstraZeneca HR+/HER2- breast cancer CAPItello-291
48 2025-11-14 Repotrectinib (Augtyro) BMS ROS1-positive metastatic NSCLC TRIDENT-1
49 2025-11-21 Nirogacestat (Ogsiveo) SpringWorks Progressing desmoid tumors DeFi
50 2025-11-25 Durvalumab (Imfinzi) AstraZeneca Resectable gastric cancer AEGEAN
51 2025-12-03 Pirtobrutinib (Jaypirca) Eli Lilly Traditional Approval: R/R CLL/SLL BRUIN
52 2025-12-12 Belzutifan (Welireg) Merck Advanced clear cell RCC LITESPARK-005
53 2025-12-19
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