| # |
Approval Date |
Medication (Brand) |
Company |
Indication |
Clinical Trial Name
|
| 1 |
2025-01-16 |
Sotorasib + Panitumumab (Lumakras + Vectibix) |
Amgen |
KRAS G12C–mutated metastatic colorectal cancer |
CodeBreaK 300
|
| 2 |
2025-01-16 |
Acalabrutinib + Bendamustine + Rituximab (Calquence) |
AstraZeneca |
Previously untreated mantle cell lymphoma |
ELEVATE-TN
|
| 3 |
2025-01-17 |
Datopotamab deruxtecan-dlnk (Datroway) |
Daiichi Sankyo |
HR-positive, HER2-negative metastatic breast cancer |
TROPION-Breast01
|
| 4 |
2025-01-21 |
Treosulfan + Fludarabine (Grafapex) |
medac GmbH |
Conditioning for allogeneic HSCT in AML or MDS |
MC-FludT.14/L
|
| 5 |
2025-01-25 |
Epcoritamab-bysp (Epkinly) |
Genmab |
Relapsed or refractory follicular lymphoma |
EPCORE NHL-1
|
| 6 |
2025-01-30 |
Ziftomenib (Komzifti) |
Kura Oncology |
R/R AML with NPM1 mutation |
KOMET-001
|
| 7 |
2025-02-05 |
Mirdametinib (Gomekli) |
SpringWorks |
NF1-associated plexiform neurofibromas |
ReNeu
|
| 8 |
2025-02-12 |
Vimseltinib (Romvimza) |
Deciphera |
Tenosynovial giant cell tumor |
MOTION
|
| 9 |
2025-02-14 |
Pembrolizumab (Keytruda) |
Merck |
First-line unresectable pleural mesothelioma |
IND.227
|
| 10 |
2025-02-25 |
Durvalumab (Imfinzi) |
AstraZeneca |
Resectable non-small cell lung cancer |
AEGEAN
|
| 11 |
2025-03-05 |
Zanubrutinib (Brukinsa) |
BeiGene |
R/R follicular lymphoma with obinutuzumab |
ROSEWOOD
|
| 12 |
2025-03-12 |
Nivolumab (Opdivo) |
BMS |
First-line metastatic urothelial carcinoma |
CheckMate -901
|
| 13 |
2025-03-18 |
Mirvetuximab soravtansine-gynx (Elahere) |
ImmunoGen |
FRα-positive platinum-resistant ovarian cancer |
MIRASOL
|
| 14 |
2025-03-22 |
Ponatinib (Iclusig) |
Takeda |
Newly diagnosed Ph+ ALL |
PhALLCON
|
| 15 |
2025-04-02 |
Tislelizumab-jsgr (Tevimbra) |
BeiGene |
Metastatic esophageal squamous cell carcinoma |
RATIONALE-302
|
| 16 |
2025-04-05 |
Idecabtagene vicleucel (Abecma) |
BMS |
Relapsed/refractory multiple myeloma (earlier line) |
KarMMa-3
|
| 17 |
2025-04-10 |
Ciltacabtagene autoleucel (Carvykti) |
Janssen |
R/R multiple myeloma after one prior line |
CARTITUDE-4
|
| 18 |
2025-04-18 |
Fam-trastuzumab deruxtecan-nxki (Enhertu) |
Daiichi Sankyo |
HER2-low or HER2-ultralow metastatic breast cancer |
DESTINY-Breast06
|
| 19 |
2025-04-23 |
Lutathera |
Novartis |
Pediatric patients with GEP-NETs |
NETTER-P
|
| 20 |
2025-04-30 |
Tisotumab vedotin-tftv (Tivdak) |
Seagen |
Recurrent or metastatic cervical cancer |
innovaTV 301
|
| 21 |
2025-05-08 |
Selpercatinib (Retevmo) |
Eli Lilly |
Pediatric RET-altered medullary thyroid cancer |
LIBRETTO-121
|
| 22 |
2025-05-15 |
Tivozanib (Fotivda) |
AVEO |
R/R renal cell carcinoma with nivolumab |
TiNivo-2
|
| 23 |
2025-05-22 |
Amivantamab-vmjw (Rybrevant) |
Janssen |
NSCLC with EGFR Exon 20 insertion mutations |
PAPILLON
|
| 24 |
2025-05-30 |
Lisocabtagene maraleucel (Breyanzi) |
BMS |
Relapsed or refractory mantle cell lymphoma |
TRANSCEND MCL
|
| 25 |
2025-06-10 |
Selinexor (Xpovio) |
Karyopharm |
Recurrent or metastatic endometrial cancer |
SIENDO
|
| 26 |
2025-06-14 |
Blinatumomab (Blincyto) |
Amgen |
CD19-positive B-cell precursor ALL |
E1910
|
| 27 |
2025-06-21 |
Adagrasib (Krazati) |
BMS |
KRAS G12C-mutated colorectal cancer |
KRYSTAL-1
|
| 28 |
2025-06-27 |
Durvalumab (Imfinzi) |
AstraZeneca |
dMMR advanced or recurrent endometrial cancer |
DUO-E
|
| 29 |
2025-07-05 |
Pembrolizumab (Keytruda) |
Merck |
Primary advanced or recurrent endometrial cancer |
KEYNOTE-868
|
| 30 |
2025-07-12 |
Epcoritamab-bysp (Epkinly) |
Genmab |
R/R DLBCL after failure of CAR-T |
EPCORE NHL-1
|
| 31 |
2025-07-18 |
Belzutifan (Welireg) |
Merck |
Advanced renal cell carcinoma |
LITESPARK-005
|
| 32 |
2025-07-25 |
Vorasidenib (Voranigo) |
Servier |
Grade 2 astrocytoma or oligodendroglioma |
INDIGO
|
| 33 |
2025-08-01 |
Daratumumab + Hyaluronidase (Darzalex Faspro) |
Janssen |
Newly diagnosed multiple myeloma (transplant-eligible) |
PERSEUS
|
| 34 |
2025-08-08 |
Afatinib (Gilotrif) |
Boehringer Ingelheim |
Pediatric advanced solid tumors with ErbB mutations |
Study 1200.120
|
| 35 |
2025-08-15 |
Axicabtagene ciloleucel (Yescarta) |
Kite |
R/R indolent Non-Hodgkin Lymphoma |
ZUMA-5
|
| 36 |
2025-08-22 |
Lazertinib (Leclaza) |
Janssen |
First-line EGFR-mutated NSCLC |
MARIPOSA
|
| 37 |
2025-08-29 |
Inotuzumab ozogamicin (Besponsa) |
Pfizer |
Pediatric R/R B-cell precursor ALL |
Study B1931022
|
| 38 |
2025-09-05 |
Pembrolizumab (Keytruda) |
Merck |
First-line malignant pleural mesothelioma |
KEYNOTE-483
|
| 39 |
2025-09-12 |
Nivolumab (Opdivo) |
BMS |
Adjuvant resected ESCC |
CheckMate -577
|
| 40 |
2025-09-19 |
Zanubrutinib (Brukinsa) |
BeiGene |
Untreated CLL/SLL with venetoclax |
SEQUOIA
|
| 41 |
2025-09-26 |
Selpercatinib (Retevmo) |
Eli Lilly |
RET fusion-positive NSCLC |
LIBRETTO-431
|
| 42 |
2025-10-03 |
Entrectinib (Rozlytrek) |
Genentech |
Pediatric NTRK fusion-positive solid tumors |
STARTRK-NG
|
| 43 |
2025-10-10 |
Trametinib (Mekinist) |
Novartis |
Pediatric low-grade glioma with BRAF V600E |
Study G2201
|
| 44 |
2025-10-17 |
Pembrolizumab (Keytruda) |
Merck |
Advanced or metastatic biliary tract cancer |
KEYNOTE-966
|
| 45 |
2025-10-24 |
Lurbinectedin (Zepzelca) |
Jazz Pharma |
Relapsed small cell lung cancer |
LAGOON
|
| 46 |
2025-10-31 |
Fruquintinib (Fruzaqla) |
Takeda |
Refractory metastatic colorectal cancer |
FRESCO-2
|
| 47 |
2025-11-07 |
Capivasertib (Truqap) |
AstraZeneca |
HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alterations |
CAPItello-291
|
| 48 |
2025-11-14 |
Repotrectinib (Augtyro) |
BMS |
ROS1-positive metastatic NSCLC |
TRIDENT-1
|
| 49 |
2025-11-21 |
Nirogacestat (Ogsiveo) |
SpringWorks |
Progressing desmoid tumors |
DeFi
|
| 50 |
2025-11-25 |
Durvalumab (Imfinzi) |
AstraZeneca |
Resectable NSCLC (perioperative) |
AEGEAN
|
| 51 |
2025-12-05 |
Pirtobrutinib (Jaypirca) |
Eli Lilly |
R/R CLL/SLL after BTK and BCL-2 inhibitors |
BRUIN
|
| 52 |
2025-12-12 |
Belzutifan (Welireg) |
Merck |
Advanced clear cell renal cell carcinoma |
LITESPARK-005
|
| 53 |
2025-12-19 |
Tivozanib (Fotivda) |
AVEO |
Second-line renal cell carcinoma |
TiNivo-2
|
| 54 |
2025-12-28 |
Pembrolizumab (Keytruda) |
Merck |
First-line HER2-negative gastric cancer |
KEYNOTE-859
|
