| # |
Approval Date |
Medication (Brand Name) |
Company |
Indication |
Clinical Trial Name
|
| 1 |
2025-01-16 |
Sotorasib (Lumakras) |
Amgen |
KRAS G12C–mutated metastatic colorectal cancer |
CodeBreaK 300
|
| 2 |
2025-01-16 |
Panitumumab (Vectibix) |
Amgen |
KRAS G12C–mutated metastatic colorectal cancer |
CodeBreaK 300
|
| 3 |
2025-01-16 |
Acalabrutinib (Calquence) |
AstraZeneca |
Previously untreated mantle cell lymphoma |
ECHO
|
| 4 |
2025-01-17 |
Datopotamab deruxtecan-dlnk (Datroway) |
Daiichi Sankyo |
HR-positive, HER2-negative metastatic breast cancer |
TROPION-Breast01
|
| 5 |
2025-01-21 |
Treosulfan (Grafapex) |
medac GmbH |
Conditioning for allogeneic HSCT in AML or MDS |
MC-FludT.14/L
|
| 6 |
2025-01-27 |
Trastuzumab deruxtecan (Enhertu) |
AstraZeneca |
HER2-low or HER2-ultralow metastatic breast cancer |
DESTINY-Breast06
|
| 7 |
2025-02-11 |
Mirdametinib (Gomekli) |
SpringWorks |
NF1-associated plexiform neurofibromas |
ReNeu
|
| 8 |
2025-02-11 |
Brentuximab vedotin (Adcetris) |
Pfizer |
Relapsed or refractory Large B-Cell Lymphoma |
ECHELON-3
|
| 9 |
2025-02-14 |
Vimseltinib (Romvimza) |
Deciphera |
Tenosynovial giant cell tumor (TGCT) |
MOTION
|
| 10 |
2025-02-14 |
Pembrolizumab (Keytruda) |
Merck |
First-line metastatic pleural mesothelioma |
IND.227
|
| 11 |
2025-03-04 |
Tislelizumab-jsgr (Tevimbra) |
BeiGene |
First-line esophageal squamous cell carcinoma |
RATIONALE-306
|
| 12 |
2025-03-05 |
Zanubrutinib (Brukinsa) |
BeiGene |
Relapsed or refractory follicular lymphoma (FL) |
ROSEWOOD
|
| 13 |
2025-03-12 |
Nivolumab (Opdivo) |
BMS |
First-line metastatic urothelial carcinoma |
CheckMate-901
|
| 14 |
2025-03-19 |
Pembrolizumab (Keytruda) |
Merck |
HER2+, PD-L1+ Gastric/GEJ Adenocarcinoma |
KEYNOTE-811
|
| 15 |
2025-03-22 |
Mirvetuximab soravtansine-gynx (Elahere) |
ImmunoGen |
FRα-positive, platinum-resistant ovarian cancer |
MIRASOL
|
| 16 |
2025-03-26 |
Cabozantinib (Cabometyx) |
Exelixis |
Pancreatic neuroendocrine tumors (pNETs) |
CABINET
|
| 17 |
2025-03-28 |
Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) |
Novartis |
Pre-taxane metastatic mCRPC |
PSMAfore
|
| 18 |
2025-04-08 |
Nivolumab (Opdivo) |
BMS |
MSI-H/dMMR metastatic colorectal cancer |
CheckMate-8HW
|
| 19 |
2025-04-10 |
Ciltacabtagene autoleucel (Carvykti) |
Janssen |
R/R Multiple Myeloma after one prior line |
CARTITUDE-4
|
| 20 |
2025-04-11 |
Nivolumab (Opdivo) |
BMS |
First-line unresectable/metastatic HCC |
CheckMate-9DW
|
| 21 |
2025-04-11 |
Ipilimumab (Yervoy) |
BMS |
First-line unresectable/metastatic HCC |
CheckMate-9DW
|
| 22 |
2025-04-23 |
Penpulimab-kcqx |
Akeso Biopharma |
Non-keratinizing nasopharyngeal carcinoma |
AK105-302
|
| 23 |
2025-05-08 |
Avutometinib |
Verastem |
KRAS-mutated recurrent low-grade serous ovarian cancer |
RAMP 201
|
| 24 |
2025-05-08 |
Defactinib (Fakzynja) |
Verastem |
KRAS-mutated recurrent low-grade serous ovarian cancer |
RAMP 201
|
| 25 |
2025-05-08 |
Selpercatinib (Retevmo) |
Eli Lilly |
Pediatric RET-altered medullary thyroid cancer |
LIBRETTO-121
|
| 26 |
2025-05-14 |
Telisotuzumab vedotin-tllv (Emrelis) |
AbbVie |
c-Met high non-squamous metastatic NSCLC |
LUMINOSITY
|
| 27 |
2025-05-14 |
Belzutifan (Welireg) |
Merck |
Pheochromocytoma or paraganglioma |
LITESPARK-013
|
| 28 |
2025-05-30 |
Lisocabtagene maraleucel (Breyanzi) |
BMS |
Relapsed or refractory Mantle Cell Lymphoma |
TRANSCEND MCL
|
| 29 |
2025-06-03 |
Darolutamide (Nubeqa) |
Bayer |
Metastatic castration-sensitive prostate cancer |
ARANOTE
|
| 30 |
2025-06-11 |
Taletrectinib (Ibtrozi) |
Nuvation Bio |
Locally advanced or metastatic ROS1+ NSCLC |
TRUST-I
|
| 31 |
2025-06-12 |
Pembrolizumab (Keytruda) |
Merck |
Resectable locally advanced HNSCC |
KEYNOTE-689
|
| 32 |
2025-06-12 |
Mitomycin intravesical solution (Zusduri) |
UroGen |
Recurrent low-grade intermediate-risk NMIBC |
ENVISION
|
| 33 |
2025-06-18 |
Tafasitamab-cxix (Monjuvi) |
Incyte |
Relapsed or refractory Follicular Lymphoma |
inMIND
|
| 34 |
2025-06-23 |
Datopotamab deruxtecan-dlnk (Datroway) |
Daiichi Sankyo |
EGFR-mutated advanced/metastatic NSCLC |
TROPION-LUNG01
|
| 35 |
2025-06-27 |
Durvalumab (Imfinzi) |
AstraZeneca |
dMMR advanced or recurrent endometrial cancer |
DUO-E
|
| 36 |
2025-07-02 |
Sunvozertinib (Zegfrovy) |
Dizal Pharma |
EGFR Exon 20 insertion mutant NSCLC |
WU-KONG6
|
| 37 |
2025-07-02 |
Linvoseltamab-gcpt (Lynozyfic) |
Regeneron |
Relapsed or refractory Multiple Myeloma |
LINKER-MM1
|
| 38 |
2025-08-06 |
Dordaviprone (Modeyso) |
Jazz |
H3 K27M-mutated diffuse midline glioma |
ONC201
|
| 39 |
2025-08-08 |
Zongertinib (Hernexeos) |
Boehringer |
HER2 TKD-mutant non-squamous NSCLC |
Beamion LUNG-1
|
| 40 |
2025-08-25 |
Leuprolide mesylate (Camcevi) |
Tolmar |
Advanced prostate cancer (3-month injection) |
FP-001 LMIS
|
| 41 |
2025-09-10 |
Selumetinib (Koselugo) |
AstraZeneca |
Pediatric NF1 plexiform neurofibromas (Granules) |
SPRINT
|
| 42 |
2025-09-19 |
Pembrolizumab subcutaneous (Keytruda Qlex) |
Merck |
Subcutaneous solid tumor indications |
MK-3475-A86
|
| 43 |
2025-09-25 |
Imlunestrant (Inluriyo) |
Eli Lilly |
ESR1-mutated advanced breast cancer |
EMBER-3
|
| 44 |
2025-10-02 |
Lurbinectedin (Zepzelca) |
Jazz |
ES-SCLC maintenance |
IMforte
|
| 45 |
2025-10-08 |
Cemiplimab-rwlc (Libtayo) |
Regeneron |
Adjuvant cutaneous squamous cell carcinoma |
C-POST
|
| 46 |
2025-10-23 |
Belantamab mafodotin-blmf (Blenrep) |
GSK |
Relapsed or refractory Multiple Myeloma |
DREAMM-7
|
| 47 |
2025-10-24 |
Revumenib (Revuforj) |
Syndax |
NPM1-mutant relapsed or refractory AML |
AUGMENT-101
|
| 48 |
2025-11-06 |
Daratumumab subcutaneous (Darzalex Faspro) |
Janssen |
High-risk smoldering multiple myeloma |
AQUILA
|
| 49 |
2025-11-13 |
Ziftomenib (Komzifti) |
Kura Oncology |
R/R AML with susceptible NPM1 mutation |
KOMET-001
|
| 50 |
2025-11-19 |
Tarlatamab-dlle (Imdelltra) |
Amgen |
Extensive stage SCLC (Full Approval) |
DeLLphi-301
|
| 51 |
2025-11-25 |
Durvalumab (Imfinzi) |
AstraZeneca |
Resectable gastric or GEJ adenocarcinoma |
MATTERHORN
|
| 52 |
2025-12-03 |
Pirtobrutinib (Jaypirca) |
Eli Lilly |
Relapsed or refractory CLL/SLL (Full Approval) |
BRUIN
|
| 53 |
2025-12-12 |
Niraparib (Akeega) |
Janssen |
BRCA2-mutated mCSPC |
MAGNITUDE
|
| 54 |
2025-12-17 |
Amivantamab subcutaneous (Rybrevant Faspro) |
Janssen |
Subcutaneous delivery for all indications |
PALOMA-3
|
