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FDA Oncology Approvals 2025: Difference between revisions

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{| class="wikitable sortable" style="width:100%; font-size:90%;"
{| class="wikitable sortable" style="width:100%; text-align:center;"
! Approval date
! Approval date
! Medication
! Medication (Brand)
! Drug class / property
! Company
! Company
! Indication
! Indication
! Regulatory type
! Regulatory type
! Key trial(s)
! Trial(s) cited on FDA approval page
! Reference
|-
|-
| 2025-01-16
| 2025-01-16
| '''Sotorasib + Panitumumab'''<br />(Lumakras + Vectibix)
| Sotorasib + Panitumumab<br/>(Lumakras + Vectibix)
| KRAS G12C inhibitor + EGFR monoclonal antibody
| Amgen
| Amgen
| KRAS G12C–mutated metastatic colorectal cancer after prior chemotherapy
| KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
| Traditional
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer CodeBreaK 300]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer CodeBreaK 300]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer Reference]
|-
|-
 
| 2025-01-16
| Acalabrutinib + Bendamustine + Rituximab<br/>(Calquence-based regimen)
| AstraZeneca
| Previously untreated mantle cell lymphoma in adults not eligible for autologous HSCT
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-mantle-cell-lymphoma ELEVATE-TN]
|-
| 2025-01-17
| 2025-01-17
| '''Datopotamab deruxtecan-dlnk'''<br />(Datroway)
| Datopotamab deruxtecan-dlnk<br/>(Datroway)
| TROP2 antibody–drug conjugate
| Daiichi Sankyo
| Daiichi Sankyo
| HR-positive, HER2-negative unresectable or metastatic breast cancer
| HR-positive, HER2-negative unresectable or metastatic breast cancer after endocrine therapy and chemotherapy
| Accelerated approval
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-breast-cancer TROPION-Breast01]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-hr-positive-her2-negative-breast-cancer TROPION-Breast01]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-breast-cancer Reference]
|-
| 2025-01-30
| Treosulfan + Fludarabine<br/>(Grafapex)
| Medac GmbH
| Conditioning regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-conditioning-allogeneic-hematopoietic-stem-cell-transplantation MC-FludT.14/L]
|-
|-
 
| 2025-02-11
| 2025-03-26
| Mirdametinib<br/>(Gomekli)
| '''Cabozantinib'''<br />(Cabometyx)
| SpringWorks Therapeutics
| Multikinase inhibitor
| Adults and children ≥2 years with NF1-associated plexiform neurofibromas
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-neurofibromatosis-type-1 ReNeu]
|-
| 2025-02-14
| Brentuximab vedotin + Lenalidomide + Rituximab
| Seagen / Bristol Myers Squibb
| Relapsed or refractory diffuse large B-cell lymphoma
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-rituximab-dlbcl ECHELON-3]
|-
| 2025-03-05
| Pembrolizumab + Trastuzumab + Chemotherapy
| Merck & Co.
| HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-trastuzumab-gastric-cancer KEYNOTE-811]
|-
| 2025-03-14
| Cabozantinib<br/>(Cabometyx)
| Exelixis
| Exelixis
| Previously treated pancreatic and extra-pancreatic neuroendocrine tumors
| Previously treated metastatic pancreatic neuroendocrine tumors
| Traditional
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-neuroendocrine-tumors CABINET]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-pancreatic-neuroendocrine-tumors CABINET]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-neuroendocrine-tumors Reference]
|-
|-
 
| 2025-04-08
| 2025-05-08
| Nivolumab + Ipilimumab
| '''Avutometinib + Defactinib'''
| Bristol Myers Squibb
| RAF/MEK inhibitor + FAK inhibitor
| MSI-H or dMMR metastatic colorectal cancer
| Verastem
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-msi-h-colorectal-cancer CheckMate-8HW]
|-
| 2025-05-02
| Avutometinib + Defactinib
| Verastem Oncology
| KRAS-mutated recurrent low-grade serous ovarian cancer
| KRAS-mutated recurrent low-grade serous ovarian cancer
| Accelerated approval
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-avutometinib-defactinib-lgsoc RAMP-201]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-avutometinib-defactinib-ovarian-cancer RAMP-201]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-avutometinib-defactinib-lgsoc Reference]
|-
|-
 
| 2025-05-14
| 2025-06-23
| Belzutifan<br/>(Welireg)
| '''Datopotamab deruxtecan-dlnk'''<br />(Datroway)
| Merck & Co.
| TROP2 antibody–drug conjugate
| Advanced sporadic clear cell renal cell carcinoma
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-advanced-clear-cell-renal-cell-carcinoma LITESPARK-005]
|-
| 2025-06-13
| Datopotamab deruxtecan-dlnk<br/>(Datroway)
| Daiichi Sankyo
| Daiichi Sankyo
| EGFR-mutated locally advanced or metastatic non-small cell lung cancer after EGFR-directed therapy and platinum chemotherapy
| EGFR-mutated locally advanced or metastatic NSCLC after EGFR-directed therapy and platinum chemotherapy
| Accelerated approval
| Accelerated approval
|
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer TROPION-Lung01]<br/>[https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer TROPION-Lung05]
[https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer TROPION-Lung01];
[https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer TROPION-Lung05]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer Reference]
 
|-
|-
| 2025-07-02
| 2025-07-02
| Sunvozertinib (Zegfrovy)
| Sunvozertinib<br/>(Zegfrovy)
| Kinase inhibitor
| Dizal Pharma
| Dizal Pharma
| EGFR exon 20 insertion NSCLC after platinum therapy
| EGFR exon 20 insertion–mutated metastatic NSCLC after platinum chemotherapy
| Accelerated approval
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20 WU-KONG1B]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20 WU-KONG1B]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20 Reference]
|-
|-
| 2025-07-02
| 2025-07-02
| Linvoseltamab-gcpt (Lynozyfic)
| Linvoseltamab-gcpt<br/>(Lynozyfic)
| BCMA × CD3 bispecific antibody
| Regeneron Pharmaceuticals
| Regeneron Pharmaceuticals
| Relapsed/refractory multiple myeloma (≥4 prior lines)
| Relapsed or refractory multiple myeloma after ≥4 prior lines of therapy
| Accelerated approval
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma LINKER-MM1]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma LINKER-MM1]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma Reference]
|-
| 2025-08-06
| Dordaviprone (Modeyso)
| Small-molecule protease activator
| Jazz Pharmaceuticals
| H3 K27M–mutant diffuse midline glioma after prior therapy
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma ONC006]<br/>[https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma ONC013]<br/>[https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma ONC014]<br/>[https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma ONC016]<br/>[https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma ONC018]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma Reference]
|-
|-
| 2025-08-08
| 2025-08-08
| Zongertinib (Hernexeos)
| Zongertinib<br/>(Hernexeos)
| Kinase inhibitor
| Boehringer Ingelheim
| Boehringer Ingelheim
| HER2 (ERBB2) TKD-mutant non-squamous NSCLC after prior systemic therapy
| HER2-mutated non-squamous NSCLC after prior systemic therapy
| Accelerated approval
| Accelerated approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations Beamion%20LUNG-1]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations Beamion LUNG-1]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations Reference]
|-
|-
| 2025-12-03
| 2025-12-03
| Pirtobrutinib (Jaypirca)
| Pirtobrutinib<br/>(Jaypirca)
| Non-covalent (reversible) BTK inhibitor
| Eli Lilly and Company
| Eli Lilly and Company
| Relapsed/refractory CLL/SLL after prior covalent BTK inhibitor
| Relapsed or refractory CLL/SLL after prior covalent BTK inhibitor
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic BRUIN-CLL-321]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic BRUIN-CLL-321]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic Reference]
|-
|-
| 2025-12-04
| 2025-12-04
| Lisocabtagene maraleucel (Breyanzi)
| Lisocabtagene maraleucel<br/>(Breyanzi)
| CD19-directed CAR T-cell therapy
| Bristol Myers Squibb
| Bristol Myers Squibb (Juno Therapeutics)
| Relapsed or refractory marginal zone lymphoma after ≥2 prior therapies
| Relapsed/refractory marginal zone lymphoma after ≥2 prior systemic therapies
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma TRANSCEND%20FL-MZL]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma TRANSCEND FL-MZL]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma Reference]
|-
|-
| 2025-12-12
| 2025-12-12
| Niraparib + abiraterone acetate + prednisone (Akeega)
| Niraparib + Abiraterone acetate + Prednisone<br/>(Akeega)
| PARP inhibitor + androgen biosynthesis inhibitor
| Janssen Biotech
| Janssen Biotech, Inc.
| BRCA2-mutated metastatic castration-sensitive prostate cancer
| BRCA2-mutated metastatic castration-sensitive prostate cancer
| Traditional approval
| Traditional approval
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration AMPLITUDE]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration AMPLITUDE]
| [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration Reference]
|}

Revision as of 20:38, 31 December 2025

Approval date Medication (Brand) Company Indication Regulatory type Trial(s) cited on FDA approval page
2025-01-16 Sotorasib + Panitumumab
(Lumakras + Vectibix) 		Amgen KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy Traditional approval CodeBreaK 300
2025-01-16 Acalabrutinib + Bendamustine + Rituximab
(Calquence-based regimen) 		AstraZeneca Previously untreated mantle cell lymphoma in adults not eligible for autologous HSCT Traditional approval ELEVATE-TN
2025-01-17 Datopotamab deruxtecan-dlnk
(Datroway) 		Daiichi Sankyo HR-positive, HER2-negative unresectable or metastatic breast cancer after endocrine therapy and chemotherapy Accelerated approval TROPION-Breast01
2025-01-30 Treosulfan + Fludarabine
(Grafapex) 		Medac GmbH Conditioning regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS Traditional approval MC-FludT.14/L
2025-02-11 Mirdametinib
(Gomekli) 		SpringWorks Therapeutics Adults and children ≥2 years with NF1-associated plexiform neurofibromas Traditional approval ReNeu
2025-02-14 Brentuximab vedotin + Lenalidomide + Rituximab Seagen / Bristol Myers Squibb Relapsed or refractory diffuse large B-cell lymphoma Traditional approval ECHELON-3
2025-03-05 Pembrolizumab + Trastuzumab + Chemotherapy Merck & Co. HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma Traditional approval KEYNOTE-811
2025-03-14 Cabozantinib
(Cabometyx) 		Exelixis Previously treated metastatic pancreatic neuroendocrine tumors Traditional approval CABINET
2025-04-08 Nivolumab + Ipilimumab Bristol Myers Squibb MSI-H or dMMR metastatic colorectal cancer Traditional approval CheckMate-8HW
2025-05-02 Avutometinib + Defactinib Verastem Oncology KRAS-mutated recurrent low-grade serous ovarian cancer Accelerated approval RAMP-201
2025-05-14 Belzutifan
(Welireg) 		Merck & Co. Advanced sporadic clear cell renal cell carcinoma Traditional approval LITESPARK-005
2025-06-13 Datopotamab deruxtecan-dlnk
(Datroway) 		Daiichi Sankyo EGFR-mutated locally advanced or metastatic NSCLC after EGFR-directed therapy and platinum chemotherapy Accelerated approval TROPION-Lung01
TROPION-Lung05
2025-07-02 Sunvozertinib
(Zegfrovy) 		Dizal Pharma EGFR exon 20 insertion–mutated metastatic NSCLC after platinum chemotherapy Accelerated approval WU-KONG1B
2025-07-02 Linvoseltamab-gcpt
(Lynozyfic) 		Regeneron Pharmaceuticals Relapsed or refractory multiple myeloma after ≥4 prior lines of therapy Accelerated approval LINKER-MM1
2025-08-08 Zongertinib
(Hernexeos) 		Boehringer Ingelheim HER2-mutated non-squamous NSCLC after prior systemic therapy Accelerated approval Beamion LUNG-1
2025-12-03 Pirtobrutinib
(Jaypirca) 		Eli Lilly and Company Relapsed or refractory CLL/SLL after prior covalent BTK inhibitor Traditional approval BRUIN-CLL-321
2025-12-04 Lisocabtagene maraleucel
(Breyanzi) 		Bristol Myers Squibb Relapsed or refractory marginal zone lymphoma after ≥2 prior therapies Traditional approval TRANSCEND FL-MZL
2025-12-12 Niraparib + Abiraterone acetate + Prednisone
(Akeega) 		Janssen Biotech BRCA2-mutated metastatic castration-sensitive prostate cancer Traditional approval AMPLITUDE
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