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 | |||||
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 | |||||
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 | |||||
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. | |||||
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
