| # |
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 |
2025-02-11 |
Mirdametinib (Gomekli) |
SpringWorks |
NF1-associated plexiform neurofibromas |
ReNeu
|
| 7 |
2025-02-14 |
Vimseltinib (Romvimza) |
Deciphera |
Tenosynovial giant cell tumor (TGCT) |
MOTION
|
| 8 |
2025-02-14 |
Pembrolizumab (Keytruda) |
Merck |
First-line metastatic pleural mesothelioma |
IND.227
|
| 9 |
2025-03-05 |
Zanubrutinib (Brukinsa) |
BeiGene |
Relapsed or refractory follicular lymphoma |
ROSEWOOD
|
| 10 |
2025-03-12 |
Nivolumab (Opdivo) |
BMS |
First-line metastatic urothelial carcinoma |
CheckMate-901
|
| 11 |
2025-04-10 |
Ciltacabtagene autoleucel (Carvykti) |
Janssen |
R/R Multiple Myeloma after one prior line |
CARTITUDE-4
|
| 12 |
2025-05-14 |
Telisotuzumab vedotin-tllv (Emrelis) |
AbbVie |
Metastatic nonsquamous NSCLC |
LUMINOSITY
|
| 13 |
2025-06-11 |
Taletrectinib (Ibtrozi) |
Nuvation Bio |
ROS1-positive metastatic NSCLC |
TRUST-I
|
| 14 |
2025-07-02 |
Linvoseltamab-gcpt (Lynozyfic) |
Regeneron |
R/R Multiple Myeloma |
LINKER-MM1
|
| 15 |
2025-08-06 |
Dordaviprone (Modeyso) |
Chimerix |
H3 K27M-mutated diffuse midline glioma |
ONC201
|
| 16 |
2025-08-08 |
Zongertinib (Hernexeos) |
Boehringer Ingelheim |
HER2-mutant metastatic NSCLC |
Beamion LUNG-1
|
| 17 |
2025-09-25 |
Imlunestrant (Inluriyo) |
Eli Lilly |
ER+/HER2- ESR1-mutated breast cancer |
EMBER-3
|
| 18 |
2025-10-24 |
Revumenib (Revuforj) |
Syndax |
R/R AML with NPM1 mutation |
AUGMENT-101
|
| 19 |
2025-11-13 |
Ziftomenib (Komzifti) |
Kura Oncology |
R/R AML with NPM1 mutation |
KOMET-001
|
| 20 |
2025-12-03 |
Pirtobrutinib (Jaypirca) |
Eli Lilly |
Traditional Approval: R/R CLL/SLL |
BRUIN
|
| 21 |
2025-12-12 |
Niraparib (Akeega) |
Janssen |
BRCA2-mutated mCSPC |
MAGNITUDE
|
| 22 |
2025-12-17 |
Amivantamab (Rybrevant Faspro) |
Janssen |
Subcutaneous NSCLC formulation |
PALOMA-3
|
