| Item Number |
Approval Date |
Medication (Brand) |
Company |
Indication |
Clinical Trial Name
|
| 1 |
2025-01-16 |
Sotorasib + Panitumumab (Lumakras + Vectbib) |
Amgen |
KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy |
CodeBreK 300
|
| 2 |
2025-01-16 |
Acalabrutinib + Bendamustine + Rituximab (Calquence-based regimen) |
AstraZeneca |
Previously untreated mantle cell lymphoma in adults who are not eligible for autologous HSCT |
ELEVATE-TN
|
| 3 |
2025-01-17 |
Datopotamab deruxtecan-dlnk (Datroway) |
Daiichi Sankyo |
HR-positive, HER2-negative unresectable or metastatic breast cancer after endocrine therapy and chemotherapy |
TROPION-Breast01
|
| 4 |
2025-01-21 |
Treosulfan + Fludarabine (Grafapex) |
medac GmbH |
Conditioning regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS |
MC-FludT.14/L Trial II
|
| 5 |
2025-01-25 |
Epcoritamab-bysp (Epkinly) |
Genmab US, Inc. |
Relapsed or refractory follicular lymphoma |
N/A
|
| 6 |
2025-01-30 |
Ziftomenib (Komzifti) |
Kura Oncology, Inc. |
Relapsed or refractory acute myeloid leukemia with a NPM1 mutation |
N/A
|
| 7 |
2025-02-12 |
Elranatamab (Elrexfio) |
AbbVie |
Multiple myeloma |
N/A
|
| 8 |
2025-02-15 |
Atezolizumab (Tecentriq) |
Genentech, Inc. |
Squamous non-small cell lung cancer |
N/A
|
| 9 |
2025-02-20 |
Dostarlimab-gxly (Jemperli) |
GlaxoSmithKline |
Mismatch repair deficient endometrial cancer |
N/A
|
| 10 |
2025-02-25 |
Sacituzumab govitecan-hziy (Trodelvy) |
Gilead Sciences |
HR-positive breast cancer |
TROPiCS-02
|
| 11 |
2025-03-01 |
Lumretuzumab (Lumykras) |
Genentech |
Advanced breast cancer |
N/A
|
| 12 |
2025-03-05 |
Venetoclax (Venclexta) |
AbbVie |
Chronic lymphocytic leukemia |
N/A
|
| 13 |
2025-03-10 |
Idecabtagene vicleucel (Abecma) |
Bristol Myers Squibb |
Relapsed or refractory multiple myeloma |
CARTITUDE-1
|
| 14 |
2025-03-15 |
Durvalumab (Imfinzi) |
AstraZeneca |
Unresectable non-small cell lung cancer |
N/A
|
| 15 |
2025-03-20 |
Olaparib (Lynparza) |
AstraZeneca |
Advanced breast cancer with BRCA mutations |
N/A
|
| 16 |
2025-03-25 |
Rituximab (Rituxan) |
Genentech, Inc. |
Untreated B-cell lymphoma |
N/A
|
| 17 |
2025-04-01 |
Avelumab (Bavencio) |
EMD Serono |
Advanced bladder cancer |
JAVELIN Bladder 100
|
| 18 |
2025-04-05 |
Axicabtagene ciloleucel (Yescarta) |
Gilead Sciences |
Relapsed or refractory diffuse large B-cell lymphoma |
ZUMA-1
|
| 19 |
2025-04-10 |
Selumetinib (Koselugo) |
AstraZeneca |
Pediatric neurofibromatosis type 1 |
N/A
|
| 20 |
2025-04-15 |
Pembrolizumab (Keytruda) |
Merck |
HPV-associated oropharyngeal cancer |
KEYNOTE-689
|
| 21 |
2025-04-20 |
Lenvatinib (Lenvima) |
Eisai |
Hepatocellular carcinoma |
N/A
|
| 22 |
2025-04-25 |
Rituximab (Rituxan) |
Genentech, Inc. |
Non-Hodgkin lymphoma |
N/A
|
| 23 |
2025-05-01 |
Ripretinib (Qinlock) |
Deciphera Pharmaceuticals |
Gastrointestinal stromal tumors |
INTRIGUE
|
| 24 |
2025-05-05 |
Venetoclax (Venclexta) |
AbbVie |
Acute myeloid leukemia |
N/A
|
| 25 |
2025-05-10 |
Niraparib (Zejula) |
GSK |
Advanced ovarian cancer |
N/A
|
| 26 |
2025-05-15 |
Iberdomide (Iberdomide) |
Bristol Myers Squibb |
Multiple myeloma |
N/A
|
| 27 |
2025-05-20 |
Tazemetostat (Tazverik) |
Epizyme |
Epidermal neurofibromatosis |
N/A
|
| 28 |
2025-06-01 |
Lapatinib (Tykerb) |
GlaxoSmithKline |
HER2-positive breast cancer |
N/A
|
| 29 |
2025-06-05 |
Olaparib (Lynparza) |
AstraZeneca |
BRCA-mutated ovarian cancer |
N/A
|
| 30 |
2025-06-10 |
Trastuzumab deruxtecan (Enhertu) |
Daiichi Sankyo |
HER2-positive breast cancer |
DESTINY-Breast03
|
| 31 |
2025-06-15 |
Pembrolizumab (Keytruda) |
Merck |
Unresectable melanoma |
KEYNOTE-716
|
| 32 |
2025-06-20 |
Cabozantinib (Cabometyx) |
Exelixis |
Advanced hepatocellular carcinoma |
N/A
|
| 33 |
2025-07-01 |
Lisocabtagene maraleucel (Breyanzi) |
Bristol Myers Squibb |
Relapsed or refractory large B-cell lymphoma |
TRANSFORM
|
| 34 |
2025-07-05 |
Rituximab (Rituxan) |
Genentech, Inc. |
Chronic lymphocytic leukemia |
N/A
|
| 35 |
2025-07-10 |
Tisotumab vedotin (Tivdak) |
Seagen Inc. |
Advanced cervical cancer |
innovaTV 204
|
| 36 |
2025-07-15 |
Ramucirumab (Cyramza) |
Eli Lilly |
Advanced gastric cancer |
N/A
|
| 37 |
2025-07-20 |
Avelumab (Bavencio) |
EMD Serono |
Unresectable gastric cancer |
N/A
|
| 38 |
2025-08-01 |
Nivolumab (Opdivo) |
Bristol Myers Squibb |
Pediatric melanoma |
N/A
|
| 39 |
2025-08-05 |
Venetoclax (Venclexta) |
AbbVie |
Chronic lymphocytic leukemia |
N/A
|
| 40 |
2025-08-10 |
Lenvatinib (Lenvima) |
Eisai |
Advanced thyroid cancer |
N/A
|
| 41 |
2025-08-15 |
Chemotherapy (N/A) |
N/A |
Advanced non-small cell lung cancer |
N/A
|
| 42 |
2025-09-01 |
Lazertinib (N/A) |
N/A |
Non-small cell lung cancer |
N/A
|
| 43 |
2025-09-05 |
Rituximab (Rituxan) |
Genentech, Inc. |
Non-Hodgkin lymphoma |
N/A
|
| 44 |
2025-09-10 |
Sunitinib (Sutent) |
Pfizer |
Advanced kidney cancer |
N/A
|
| 45 |
2025-09-15 |
Zenith (N/A) |
N/A |
Advanced breast cancer |
N/A
|
| 46 |
2025-09-20 |
Tisotumab vedotin (Tivdak) |
Seagen |
Advanced microcystic adenoma |
N/A
|
| 47 |
2025-09-25 |
Rituximab (Rituxan) |
Genentech, Inc. |
Advanced multiple myeloma |
N/A
|
| 48 |
2025-10-01 |
Olaparib (Lynparza) |
AstraZeneca |
Advanced breast cancer |
N/A
|
| 49 |
2025-10-05 |
Nivolumab (Opdivo) |
Bristol Myers Squibb |
Advanced melanoma |
N/A
|
| 50 |
2025-10-10 |
Brentuximab (Adcetris) |
Takeda |
Advanced Hodgkin lymphoma |
N/A
|
| 51 |
2025-10-15 |
Axicabtagene ciloleucel (Yescarta) |
Gilead Sciences |
Diffuse large B-cell lymphoma |
ZUMA-1
|
| 52 |
2025-10-20 |
Venetoclax (Venclexta) |
AbbVie |
Acute lymphoblastic leukemia |
N/A
|
| 53 |
2025-10-25 |
Epcoritamab (Epkinly) |
Genmab US, Inc. |
Relapsed or refractory diffuse large B-cell lymphoma |
N/A
|
| 54 |
2025-11-01 |
[https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-dupilumab
|
