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Most FDA and EMA Oncology Drug Approvals in Q2 2025 Were Indication Expansions for Previously Approved Therapies

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

https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

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