2025 FDA Approvals in Cancer Treatment: How 54 New Cancer Drugs Changed Oncology
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2025 FDA Oncology Report
A Year of Convenience, Precision, and New Targets
Total Approvals
54
Leading Category
Hematology (14)
Trend of the Year
Subcutaneous Formulations
Approval Distribution
Hemato (14)
Lung (10)
Urology (9)
Gastrointestinal (8)
Breast (5)
Drug Classes
2025 Approval Details
DECEMBER 6 Approvals
17.12
GENERAL
Amivantamab + Hyaluronidase (Rybrevant Faspro)
For all approved indications of intravenous amivantamab, a subcutaneous (under-the-skin) injectable formulation was approved.
17.12
PROSTATE
Rucaparib (Rubraca)
Regular approval for BRCA-mutated mCRPC.
15.12
BREAST
T-DXd + Pertuzumab
Combination approval for first-line treatment of metastatic HER2-positive breast cancer.
12.12
PROSTATE
Niraparib + Abiraterone (Akeega)
Use with prednisone in BRCA2-mutated mCSPC.
04.12
LYMPHOMA
Lisocabtagene Maraleucel (Breyanzi)
CAR-T approval for relapsed/refractory marginal zone lymphoma (MZL).
03.12
LEUKEMIA
Pirtobrutinib (Jaypirca)
Traditional full approval for CLL/SLL patients.
NOVEMBER 9 Approvals
OCTOBER 4 Approvals
24.10
LEUKEMIA
Revumenib (Revuforj)
Menin inhibitor for NPM1-mutated relapsed AML.
23.10
MYELOMA
Belantamab Mafodotin
Bortezomib/dexamethasone combination for relapsed MM.
08.10
SKIN
Cemiplimab (Libtayo)
Adjuvant treatment for high-risk CSCC.
02.10
LUNG
Lurbinectedin + Atezolizumab
Approval for SCLC maintenance treatment.
SEPTEMBER 4 Approvals
25.09
BREAST
Imlunestrant (Inluriyo)
Oral SERD for ER+/HER2-/ESR1-mutated breast cancer.
19.09
GENERAL
Pembrolizumab SC (Keytruda Qlex)
Approval of a subcutaneous formulation for solid tumors.
10.09
PEDIATRIC
Selumetinib
Granule/capsule approval for pediatric NF1 patients.
09.09
BLADDER
Gemcitabine Intravesical
Intravesical delivery system for NMIBC.
AUGUST 2 Approvals
08.08
LUNG
Zongertinib (Hernexeos)
Approval for HER2 TKD-mutated NSCLC.
06.08
BRAIN
Dordaviprone
Approval for H3 K27M-mutated diffuse midline glioma (DMG).
JULY 2 Approvals
02.07
LUNG
Sunvozertinib (Zegfrovy)
Approval for EGFR exon 20-mutated NSCLC.
02.07
MYELOMA
Linvoseltamab
Approval of a BCMA-targeted bispecific antibody.
JUNE 6 Approvals
23.06
LUNG
Datopotamab Deruxtecan
T-DXd approval for EGFR-mutated NSCLC.
18.06
LYMPHOMA
Tafasitamab (Monjuvi)
Combination approval for follicular lymphoma.
12.06
HEAD AND NECK
Pembrolizumab
Perioperative approval for locally advanced HNSCC.
12.06
BLADDER
Mitomycin Intravesical
Approval for intermediate-risk NMIBC.
11.06
LUNG
Taletrectinib (Ibtrozi)
Approval for ROS1-positive NSCLC.
03.06
PROSTATE
Darolutamide (Nubeqa)
Indication expansion for mCSPC.
MAY 4 Approvals
15.05
ANAL
Retifanlimab (Zynyz)
Approval for anal canal cancer.
14.05
LUNG
Telisotuzumab Vedotin
ADC approval for c-Met-high NSCLC.
14.05
RARE
Belzutifan
Approval for pheochromocytoma/paraganglioma.
08.05
GYNECOLOGIC
Avutometinib + Defactinib
Approval for KRAS-mutated ovarian cancer (LGSOC).
APRIL 3 Approvals
23.04
HEAD AND NECK
Penpulimab
Approval for nasopharyngeal carcinoma (NPC).
11.04
LIVER
Nivolumab + Ipilimumab
First-line approval for HCC.
08.04
COLON
Nivolumab + Ipilimumab
Approval for MSI-H/dMMR colorectal cancer.
MARCH 4 Approvals
28.03
BLADDER
Durvalumab
Perioperative approval for MIBC.
28.03
PROSTATE
Lu-177 (Pluvicto)
Indication expansion for PSMA+ mCRPC.
26.03
NEUROENDOCRINE
Cabozantinib
Approval for pNET and epNET.
19.03
STOMACH
Pembrolizumab
1st-line approval for HER2+ gastric cancer.
FEBRUARY 3 Approvals
14.02
RARE
Vimseltinib
Approval for TGCT treatment.
11.02
LYMPHOMA
Brentuximab Vedotin
Combination approval for LBCL.
11.02
RARE
Mirdametinib
Approval for NF1 plexiform neurofibromas.
JANUARY 6 Approvals
27.01
BREAST
T-DXd (Enhertu)
HER2-Ultralow breast cancer approval.
21.01
HEMATOLOGY
Treosulfan
Conditioning regimen for stem cell transplantation.
17.01
BREAST
Datopotamab Deruxtecan
Approval for HR+/HER2- metastatic breast cancer.
16.01
COLON
Sotorasib + Panitumumab
Approval for KRAS G12C-mutated mCRC.
16.01
LYMPHOMA
Acalabrutinib
1st-line approval for mantle cell lymphoma.
DROZDOGAN Academy Notes
1. The Convenience Revolution
Immunotherapies (Keytruda, Opdivo) and amivantamab now have subcutaneous (SC) formulations. Infusion times have fallen to minutes.
2. Targeted Diversity
Precision treatments were approved for specific targets such as NPM1 (leukemia), DLL3 (SCLC), and KRAS G12C (colon).
3. Boundaries Removed
T-DXd introduced the "HER2-Ultralow" category. Breast cancer patients labeled negative can now receive targeted drugs.
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