| 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 who are 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
|
| 2025-01-21
|
Treosulfan + Fludarabine (Grafapex)
|
medac GmbH
|
Conditioning regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS
|
Traditional approval
|
MC-FludT.14/L Trial II
|
| 2025-01-27
|
Fam-trastuzumab deruxtecan-nxki (Enhertu)
|
Daiichi Sankyo
|
HR-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer
|
Traditional approval
|
DESTINY-Breast06
|
| 2025-02-11
|
Mirdametinib (Gomekli)
|
SpringWorks Therapeutics
|
Adult and pediatric patients ≥2 years with NF1-associated symptomatic plexiform neurofibromas
|
Traditional approval
|
ReNeu
|
| 2025-02-11
|
Brentuximab vedotin + Lenalidomide + Rituximab
|
Seagen (Pfizer)
|
Relapsed or refractory large B-cell lymphoma in patients ineligible for autologous HSCT or CAR-T therapy
|
Traditional approval
|
ECHELON-3
|
| 2025-02-14
|
Vimseltinib (Romvimza)
|
Deciphera Pharmaceuticals
|
Tenosynovial giant cell tumor where surgical resection would cause severe morbidity
|
Traditional approval
|
MOTION
|
| 2025-03-19
|
Pembrolizumab + Trastuzumab + Chemotherapy
|
Merck
|
First-line treatment of HER2-positive gastric or gastroesophageal junction adenocarcinoma (PD-L1 CPS ≥1)
|
Traditional approval
|
KEYNOTE-811
|
| 2025-03-26
|
Cabozantinib (Cabometyx)
|
Exelixis
|
Previously treated, unresectable or metastatic pancreatic neuroendocrine tumors and extra-pancreatic neuroendocrine tumors
|
Traditional approval
|
CABINET
|
| 2025-03-28
|
Lutetium Lu-177 vipivotide tetraxetan (Pluvicto)
|
Novartis
|
PSMA-positive metastatic castration-resistant prostate cancer
|
Traditional approval
|
PSMAfore
|
| 2025-04-08
|
Nivolumab + Ipilimumab
|
Bristol Myers Squibb
|
Unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer
|
Traditional approval
|
CheckMate-8HW
|
| 2025-04-11
|
Nivolumab + Ipilimumab
|
Bristol Myers Squibb
|
First-line treatment of unresectable or metastatic hepatocellular carcinoma
|
Traditional approval
|
CheckMate-9DW
|
| 2025-04-23
|
Penpulimab-kcqx
|
Akeso Biopharma
|
First-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma
|
Traditional approval
|
AK105-304; AK105-202
|
| 2025-05-08
|
Avutometinib + Defactinib
|
Verastem
|
KRAS-mutated recurrent low-grade serous ovarian cancer after prior systemic therapy
|
Accelerated approval
|
RAMP-201
|
| 2025-05-14
|
Belzutifan (Welireg)
|
Merck
|
Locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma
|
Traditional approval
|
LITESPARK-015
|
| 2025-05-14
|
Telisotuzumab vedotin-tllv (Emrelis)
|
AbbVie
|
c-MET–overexpressing non-small cell lung cancer after prior systemic therapy
|
Accelerated approval
|
LUMINOSITY
|
| 2025-05-15
|
Retifanlimab-dlwr (Zynyz)
|
Incyte
|
Squamous cell carcinoma of the anal canal (first-line with chemotherapy or as monotherapy after platinum)
|
Traditional approval
|
POD1UM-303; POD1UM-202
|
| 2025-06-11
|
Taletrectinib (Ibtrozi)
|
Nuvation Bio
|
Locally advanced or metastatic ROS1-positive non-small cell lung cancer
|
Traditional approval
|
TRUST-I; TRUST-II
|
| 2025-06-23
|
Datopotamab deruxtecan-dlnk (Datroway)
|
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
|
| 2025-07-02
|
Sunvozertinib (Zegfrovy)
|
Dizal Pharma
|
EGFR exon 20 insertion NSCLC after platinum therapy
|
Accelerated approval
|
WU-KONG1
|
| 2025-07-02
|
Linvoseltamab-gcpt (Lynozyfic)
|
Regeneron
|
Relapsed/refractory multiple myeloma (≥4 prior lines)
|
Accelerated approval
|
LINKER-MM1
|
| 2025-08-06
|
Dordaviprone (Modeyso)
|
Jazz Pharmaceuticals
|
H3 K27M–mutant diffuse midline glioma
|
Accelerated approval
|
ACTION
|
| 2025-08-08
|
Zongertinib (Hernexeos)
|
Boehringer Ingelheim
|
HER2-mutated NSCLC after prior therapy
|
Accelerated approval
|
BEAMION-LUNG-1
|
| 2025-09-09
|
Gemcitabine intravesical system (Inlexzo)
|
Janssen
|
BCG-unresponsive NMIBC with CIS
|
Traditional approval
|
SUNRISE-1
|
| 2025-09-25
|
Imlunestrant (Inluriyo)
|
Eli Lilly
|
ESR1-mutated ER+/HER2− metastatic breast cancer
|
Traditional approval
|
EMBER-3
|
| 2025-10-24
|
Revumenib (Revuforj)
|
Syndax Pharmaceuticals
|
Relapsed/refractory NPM1-mutated AML
|
Accelerated approval
|
AUGMENT-101
|
| 2025-11-13
|
Ziftomenib (Komzifti)
|
Kura Oncology
|
Relapsed/refractory NPM1-mutated AML
|
Accelerated approval
|
KOMET-001
|
| 2025-11-18
|
Epcoritamab-bysp (Epkinly)
|
Genmab
|
Relapsed/refractory follicular lymphoma
|
Traditional approval
|
EPCORE-NHL-1
|
| 2025-12-04
|
Lisocabtagene maraleucel (Breyanzi)
|
Bristol Myers Squibb
|
Relapsed/refractory marginal zone lymphoma
|
Traditional approval
|
TRANSCEND-NHL-001
|
