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FDA Oncology Approvals 2025: Difference between revisions

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{{FDA_Approvals_2025}}
{| class="wikitable sortable" style="width:100%; font-size:90%;"
[[Category:FDA approvals]]
! Approval date
[[Category:Oncology]]
! Medication
! Drug class / property
! Company
! Indication
! Regulatory type
! Key trial(s)
! Reference
|-
 
| 2025-01-16
| '''Sotorasib + Panitumumab'''<br />(Lumakras + Vectibix)
| KRAS G12C inhibitor + EGFR monoclonal antibody
| Amgen
| KRAS G12C–mutated metastatic colorectal cancer after prior chemotherapy
| Traditional
| [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]
|-
 
| 2025-01-17
| '''Datopotamab deruxtecan-dlnk'''<br />(Datroway)
| TROP2 antibody–drug conjugate
| Daiichi Sankyo
| HR-positive, HER2-negative unresectable or metastatic breast cancer
| 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-breast-cancer Reference]
|-
 
| 2025-03-26
| '''Cabozantinib'''<br />(Cabometyx)
| Multikinase inhibitor
| Exelixis
| Previously treated pancreatic and extra-pancreatic neuroendocrine tumors
| Traditional
| [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-neuroendocrine-tumors Reference]
|-
 
| 2025-05-08
| '''Avutometinib + Defactinib'''
| RAF/MEK inhibitor + FAK inhibitor
| Verastem
| KRAS-mutated recurrent low-grade serous ovarian cancer
| 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-lgsoc Reference]
|-
 
| 2025-06-23
| '''Datopotamab deruxtecan-dlnk'''<br />(Datroway)
| TROP2 antibody–drug conjugate
| Daiichi Sankyo
| EGFR-mutated locally advanced or metastatic non-small cell lung cancer after EGFR-directed therapy and platinum chemotherapy
| 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];
[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
| Sunvozertinib (Zegfrovy)
| Kinase inhibitor
| Dizal Pharma
| EGFR exon 20 insertion NSCLC after platinum therapy
| 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 Reference]
|-
| 2025-07-02
| Linvoseltamab-gcpt (Lynozyfic)
| BCMA × CD3 bispecific antibody
| Regeneron Pharmaceuticals
| Relapsed/refractory multiple myeloma (≥4 prior lines)
| 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 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
| Zongertinib (Hernexeos)
| Kinase inhibitor
| Boehringer Ingelheim
| HER2 (ERBB2) TKD-mutant non-squamous NSCLC after prior systemic therapy
| 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 Reference]
|-
| 2025-12-03
| Pirtobrutinib (Jaypirca)
| Non-covalent (reversible) BTK inhibitor
| Eli Lilly and Company
| Relapsed/refractory CLL/SLL after prior covalent BTK inhibitor
| 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 Reference]
|-
| 2025-12-04
| Lisocabtagene maraleucel (Breyanzi)
| CD19-directed CAR T-cell therapy
| Bristol Myers Squibb (Juno Therapeutics)
| Relapsed/refractory marginal zone lymphoma after ≥2 prior systemic therapies
| 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 Reference]
|-
| 2025-12-12
| Niraparib + abiraterone acetate + prednisone (Akeega)
| PARP inhibitor + androgen biosynthesis inhibitor
| Janssen Biotech, Inc.
| BRCA2-mutated metastatic castration-sensitive prostate cancer
| 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 Reference]

Revision as of 20:30, 31 December 2025

Approval date Medication Drug class / property Company Indication Regulatory type Key trial(s) Reference
2025-01-16 Sotorasib + Panitumumab
(Lumakras + Vectibix) 		KRAS G12C inhibitor + EGFR monoclonal antibody Amgen KRAS G12C–mutated metastatic colorectal cancer after prior chemotherapy Traditional CodeBreaK 300 Reference
2025-01-17 Datopotamab deruxtecan-dlnk
(Datroway) 		TROP2 antibody–drug conjugate Daiichi Sankyo HR-positive, HER2-negative unresectable or metastatic breast cancer Accelerated approval TROPION-Breast01 Reference
2025-03-26 Cabozantinib
(Cabometyx) 		Multikinase inhibitor Exelixis Previously treated pancreatic and extra-pancreatic neuroendocrine tumors Traditional CABINET Reference
2025-05-08 Avutometinib + Defactinib RAF/MEK inhibitor + FAK inhibitor Verastem KRAS-mutated recurrent low-grade serous ovarian cancer Accelerated approval RAMP-201 Reference
2025-06-23 Datopotamab deruxtecan-dlnk
(Datroway) 		TROP2 antibody–drug conjugate Daiichi Sankyo EGFR-mutated locally advanced or metastatic non-small cell lung cancer after EGFR-directed therapy and platinum chemotherapy Accelerated approval

TROPION-Lung01; TROPION-Lung05

Reference
2025-07-02 Sunvozertinib (Zegfrovy) Kinase inhibitor Dizal Pharma EGFR exon 20 insertion NSCLC after platinum therapy Accelerated approval WU-KONG1B Reference
2025-07-02 Linvoseltamab-gcpt (Lynozyfic) BCMA × CD3 bispecific antibody Regeneron Pharmaceuticals Relapsed/refractory multiple myeloma (≥4 prior lines) Accelerated approval LINKER-MM1 Reference
2025-08-06 Dordaviprone (Modeyso) Small-molecule protease activator Jazz Pharmaceuticals H3 K27M–mutant diffuse midline glioma after prior therapy Accelerated approval ONC006
ONC013
ONC014
ONC016
ONC018 		Reference
2025-08-08 Zongertinib (Hernexeos) Kinase inhibitor Boehringer Ingelheim HER2 (ERBB2) TKD-mutant non-squamous NSCLC after prior systemic therapy Accelerated approval Beamion%20LUNG-1 Reference
2025-12-03 Pirtobrutinib (Jaypirca) Non-covalent (reversible) BTK inhibitor Eli Lilly and Company Relapsed/refractory CLL/SLL after prior covalent BTK inhibitor Traditional approval BRUIN-CLL-321 Reference
2025-12-04 Lisocabtagene maraleucel (Breyanzi) CD19-directed CAR T-cell therapy Bristol Myers Squibb (Juno Therapeutics) Relapsed/refractory marginal zone lymphoma after ≥2 prior systemic therapies Traditional approval TRANSCEND%20FL-MZL Reference
2025-12-12 Niraparib + abiraterone acetate + prednisone (Akeega) PARP inhibitor + androgen biosynthesis inhibitor Janssen Biotech, Inc. BRCA2-mutated metastatic castration-sensitive prostate cancer Traditional approval AMPLITUDE Reference
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