The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved 38 new or expanded indications for previously approved agents and 6 new oncology agents in the second quarter of 2025. The approvals included approximately 19 solid tumor types and 7 hematologic malignancies. Approximately two-thirds of the approvals were for biologics or biosimilars; there were 20 biologic approvals, and 9 biosimilar approvals, 3 of which were new agents. There was one drug approved by both the FDA and the EMA, (darolutamide; Nubeqa®; Bayer) with an indication expansion for the treatment of prostate cancer.
Additional highlights from the first quarter of 2025:
- Belzutifan (Welireg™; Merck & Co) became the first FDA approval of an oral therapy for pheochromocytoma or paraganglioma, rare types of neuroendocrine tumors
- Mitomycin (Zusduri™; UroGen Pharma), an intravesical solution, is the first and only medication FDA approved for recurrent low-grade, intermediate-risk, nonmuscle-invasive bladder cancer
- Pembrolizumab (Keytruda®; Merck) FDA approval represents the first approval for head and neck squamous cell carcinoma (HNSCC) in 6 years and the first overall perioperative approval for locally advanced HNSCC
- The tumor types with the most approvals were non-small cell lung cancer (NSCLC; 4 approvals), prostate cancer (3 approvals), colorectal cancer (CRC; 3 approvals), breast cancer (3 approvals), and multiple myeloma (3 approvals)
- There were 10 supportive care approvals, including 5 denosumab biosimilars approved by the EMA
- Three products that previously received accelerated approval gained full approval by the FDA
- Ipilimumab (Yervoy®; Bristol Myers Squibb) for the treatment of CRC and hepatocellular carcinoma (HCC)
- Larotrectinib (Vitrakvi®; Bayer) approved for treatment of solid tumors with neurotrophic tyrosine receptor kinase (NTRK) gene fusion
- Nivolumab (Opdivo®; Bristol Myers Squibb) for treatment of CRC and HCC
- Drug approvals encompassed 16 different molecular targets; the most common were programmed cell death protein 1 (PD-1; 6 approvals), receptor activator of nuclear factor kappa beta (RANKL; 5 approvals), cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4; 2 approvals), and Bruton tyrosine kinase (BTK; 2 approvals)
- There were 4 antibody-drug conjugate approvals and 4 monoclonal antibody approvals
- The FDA also approved 1 companion diagnostic: the Ventana® MET (SP44) RxDx Assay (Roche Diagnostics) to identify patients with NSCLC who may be eligible for telisotuzumab vedotin-tllv (Emrelis™; AbbVie)
- The niraparib (Zejula; GSK) indication for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer was narrowed to patients with homologous recombination deficiency-positive tumors only
The tables below summarize key oncology approvals in Q2 2025. Treatments in bold font represent new agent approvals; all others are indication expansions or conversion from accelerated to full approval (FDA).
FDA and EMA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manufacturer |
Approval |
Darolutamide |
Nubeqa |
Prostate cancer |
Androgen receptor inhibitor |
Bayer |
6/3/25 (FDA) June 2025 (EMA positive opinion) |
FDA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manufacturer |
Approval |
Avutometinib + defactinib |
Avmapki™ Fakzynja™ Co-Pack |
Low-grade serous ovarian cancer |
MEK1 inhibitor + FAK and Pyk2 inhibitor |
Verastem |
5/8/25b |
Belzutifan |
Welireg |
Pheochromocytoma or paraganglioma |
Hypoxia-inducible factor inhibitor |
Merck & Co |
5/14/25 |
Bevacizumab-nwgdc |
Jobevne™ |
CRC; NSCLC; glioblastoma; RCC; cervical, epithelial ovarian, fallopian tube, or primary peritoneal cancer |
VEGF inhibitor |
Biocon Biologics |
4/9/25 |
Datopotamab deruxtecan-dlnkd |
Datroway® |
NSCLC |
Antibody-drug conjugate |
Daiichi Sankyo |
6/23/25b |
Filgrastim-ayowc |
Releuko® |
Supportive care |
Leukocyte growth factor |
Amneal Pharmaceuticals |
4/29/25 |
Ipilimumabd |
Yervoy |
CRC |
CTLA-4 inhibitor |
Bristol Myers Squibb |
4/8/25 |
Ipilimumabd |
Yervoy |
HCC |
CTLA-4 inhibitor |
Bristol Myers Squibb |
4/11/25 |
Larotrectinib |
Vitrakvi |
Solid tumors |
TRK inhibitor |
Bayer |
4/9/25 |
Mitomycin |
Zusduri |
Bladder cancer |
Alkylating agent |
UroGen Pharma |
6/12/25 |
Nivolumabd |
Opdivo |
CRC |
PD-1 inhibitor |
Bristol Myers Squibb |
4/8/25 |
Nivolumabd |
Opdivo |
HCC |
PD-1 inhibitor |
Bristol Myers Squibb |
4/11/25 |
Palbociclib |
Ibrance® |
Breast cancer |
CDK4/6 inhibitor |
Pfizer |
4/23/25 |
Palonosetron |
Posfrea™ |
Supportive care |
Antiemetic |
Avyxa Pharma |
4/16/25 |
Pegfilgrastim-pbbkd |
Fylnetra™ |
Hematopoietic subsyndrome of acute radiation syndrome |
G-CSF |
Amneal Pharmaceuticals |
4/23/25 |
Pembrolizumabd |
Keytruda |
HNSCC |
PD-1 inhibitor |
Merck |
6/12/25 |
Penpulimab-kcqxd |
Penpulimab-kcqxb |
Nasopharyngeal carcinoma |
PD-1 inhibitor |
Akeso Biopharma |
4/23/25 |
Retifanlimab-dlwrd |
Zynyz® |
Squamous cell carcinoma of the anal canal |
PD-1 inhibitor |
Incyte Corporation |
5/15/25 |
Tafasitamab-cxixd |
Monjuvi® |
Follicular lymphoma |
CD19-directed cytolytic antibody |
Incyte Corporation |
6/18/25 |
Talazoparib |
Talzenna® |
Prostate cancer |
PARP inhibitor |
Pfizer |
6/12/25 |
Taletrectinib |
Ibtrozi™ |
NSCLC |
ROS1 inhibitor |
Nuvation Bio |
6/11/25 |
Telisotuzumab vedotin-tllvd |
Emrelis |
NSCLC |
Antibody-drug conjugate |
AbbVie |
5/14/25b |
EMA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manufacturer |
Approval |
Acalabrutinib |
Calquence® |
CLL |
BTK inhibitor |
AstraZeneca |
April 2025 |
Belantamab mafodotind |
Blenrep |
Multiple myeloma |
Antibody-drug conjugate |
GSK |
May 2025 |
Brentuximab vedotind |
Adcetris® |
Hodgkin lymphoma |
Antibody-drug conjugate |
Takeda Pharma |
April 2025 |
Cabozantinib |
Cabometyx® |
pNET and epNET |
Tyrosine kinase inhibitor |
Ipsen Pharma |
June 2025 |
Daratumumabd |
Darzalex® |
Smoldering multiple myeloma |
CD38-directed cytolytic antibody |
Janssen-Cilag |
June 2025 |
Denosumabc |
Denbrayce |
Skeletal-related events in advanced malignancies and giant cell bone tumor |
RANKL inhibitor |
Mabxience Research |
April 2025 |
Denosumabc |
Enwylma |
Skeletal-related events in advanced malignancies and giant cell bone tumor |
RANKL inhibitor |
Zentiva |
April 2025 |
Denosumabc |
Vevzuo® |
Skeletal-related events in advanced malignancies and giant cell bone tumor |
RANKL inhibitor |
Biosimilar Collaborations Ireland |
April 2025 |
Denosumabc |
Yaxwer® |
Skeletal-related events in advanced malignancies and giant cell bone tumor |
RANKL inhibitor |
Gedeon Richter |
April 2025 |
Denosumabc |
Bomyntra® |
Skeletal-related events in advanced malignancies and giant cell bone tumor |
RANKL inhibitor |
Fresenius Kabi Deutschland |
May 2025 |
Dorocubicel/allogeneic umbilical cord-derived CD34 cells, non-expandedd |
Zemcelpro® |
Hematologic malignancies |
Cell therapy |
Cordex Biologics |
June 2025 |
Durvalumabd |
Imfinzi® |
Bladder cancer |
PD-L1 inhibitor |
AstraZeneca |
May 2025 |
Ibrutinib |
Imbruvica® |
Mantle cell lymphoma |
BTK inhibitor |
Janssen-Cilag |
June 2025 |
Inavolisib |
Itovebi™ |
Breast cancer |
PI3K inhibitor |
Roche |
May 2025 |
Isatuximabd |
Sarclisa® |
Multiple myeloma |
CD38-directed monoclonal antibody |
Sanofi Winthrop Industrie |
June 2025 |
Nirogacestat |
Ogsiveo® |
Desmoid tumors |
Gamma secretase inhibitor |
SpringWorks Therapeutics |
June 2025 |
Obecabtagene autoleuceld |
Aucatzyl® |
Acute lymphoblastic leukemia |
CAR T-cell therapy |
Autolus |
May 2025 |
Pegfilgrastimc |
Vivlipeg® |
Neutropenia |
G-CSF |
Biosimilar Collaborations Ireland |
June 2025 |
Sargramostim |
Imreplys® |
Hematopoietic acute radiation syndrome |
GM-CSF |
Partner Therapeutics |
June 2025 |
Tislelizumabd |
Tevimbra® |
Nasopharyngeal carcinoma |
PD-1 inhibitor |
BeOne Medicines Ireland |
May 2025 |
Trastuzumabc |
Dazublys® |
Breast cancer |
Monoclonal antibody |
CuraTeQ Biologics |
April 2025 |
Zanidatamabd |
Ziihera® |
Biliary tract cancer |
HER2-targeted bispecific antibody |
Jazz Pharmaceuticals Ireland |
April 2025e |
aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.bAccelerated approval.cBiosimilar.dBiologic.eConditional marketing authorization.BTK, Bruton tyrosine-kinase; CAR, chimeric antigen receptor; CDK4/6, cyclin-dependent kinases 4 and 6; CLL, chronic lymphocytic leukemia; CRC, colorectal cancer; CTLA-4, cytotoxic T-lymphocyte–associated antigen 4; EMA, European Medicines Agency; epNET, extra-pancreatic neuroendocrine tumor; FAK, focal adhesion kinase; FDA, US Food and Drug Administration; G-CSF, granulocyte colony-stimulating factor; GM-CSF, granulocyte macrophage colony-stimulating factor; HCC, hepatocellular carcinoma; HER2, human epidermal growth factor receptor 2; HNSCC, head and neck squamous cell carcinoma; MEK1, mitogen-activated protein kinase kinase 1; MOA, mechanism of action; NSCLC, non-small cell lung cancer; PARP, poly (ADP-ribose) polymerase; PD-1, programmed cell death protein 1; PD-L1, PD-1 ligand 1; PI3K, phosphoinositide 3-kinase; pNET, pancreatic neuroendocrine tumor; Pyk2, proline-rich tyrosine kinase-2; RANKL, receptor activator of nuclear factor kappa beta; RCC, renal cell carcinoma; ROS1, ROS proto-oncogene 1; TRK, tropomyosin receptor kinase; VEGF, vascular endothelial growth factor. |
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Sources:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights
