The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved 21 new or expanded indications for previously approved agents and 6 new oncology agents in the third quarter of 2025. The approvals included approximately 25 solid tumor types and 6 hematologic malignancies. Approximately half of the approvals were for biologics or biosimilars; there were 7 biosimilar and 8 biologic approvals, only 1 of which was a new agent. One biosimilar was approved by both the FDA and the EMA (denosumab-nxxp, Bilprevda®, Organon and Henlius/Shanghai Henlius Biotech), and 2 additional agents were approved by just the FDA (denosumab-kyqq, Aukelso™, Biocon Biologics Ltd; denosumab-qbde, Xtrenbo™, Gedeon Richter and Hikma Pharmaceuticals) for treatment of skeletal-related events in advanced malignancies and giant cell tumor of bone.
Additional highlights from the third quarter of 2025
- Drug approvals encompassed 15 different modes of action; the most common were PD-1 inhibitors (6 approvals), RANKL inhibitors (7 approvals), EGFR inhibitors (2 approvals), MEK inhibitors (2 approvals), and bispecifics (2 approvals)
- The tumor types with the most approvals were bone (7), non-small cell lung cancer (NSCLC; 6), brain (3), breast cancer (3), and head and neck squamous cell carcinoma (3)
- Pembrolizumab and denosumab biosimilars accounted for 44% of Q3 approvals by both agencies
- Treatments for 3 rare brain tumors were approved
- Under accelerated approval, the FDA approved dordaviprone (Modeyso™; Jazz Pharmaceuticals), the first FDA approval of a systemic therapy for H3 K27M-mutant diffuse midline glioma, an ultra-rare and aggressive brain tumor that primarily affects children and young adults
- The EMA approved vorasidenib (Voranigo®; Les Laboratoires Servier) for treatment of astrocytoma or oligodendroglioma, 2 rare, malignant brain tumors
- The FDA also approved a new gemcitabine intravesical system (Inlexzo™; Janssen Biotech) for treatment of bladder cancer, the first intravesical system enabling extended release of gemcitabine into the bladder
- A new, subcutaneously administered formulation of pembrolizumab (Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph; Merck) was approved by the EMA and by the FDA for several tumor types, including tumor mutational burden-high solid tumors
- There were 7 denosumab biosimilar approvals, including 3 by the FDA and 4 by the EMA
- 2 products that previously received accelerated approval gained full approval by the FDA
- Lazertinib mesylate (Lazcluze®; Janssen Biotech) for the treatment of NSCLC
- Pembrolizumab (Keytruda®; Merck), for treatment of Hodgkin lymphoma and primary mediastinal large B-cell lymphoma
- The FDA also approved 3 companion diagnostics
- The Guardant360® CDx assay to identify patients with breast cancer with ESR1 mutations who may be eligible for treatment with imlunestrant (Inluriyo™; Eli Lilly)
- The Oncomine™ Dx Express Test (Life Technologies Corporation), to aid in detection of EGFR exon 20 insertion mutations in patients with NSCLC who may be eligible for treatment with sunvozertinib (Zegfrovy®; Dizal Jiangsu)
- The Oncomine Dx Target Test (Life Technologies Corporation), to aid in detecting HER2 (ERBB2) tyrosine kinase domain-activating mutations in patients with nonsquamous NSCLC who may be eligible for treatment with zongertinib (Hernexeos®; Boehringer Ingelheim)
The tables below summarize key oncology approvals in Q3 2025. Treatments in bold font represent new agent approvals; all others are biosimilars, indication expansions, or conversion from accelerated to full approval (FDA).
FDA and EMA Approvals
| Generic Name | Brand Name | Tumor Typea | MOA | Manufacturer | Approval |
Denosumab-nxxpb | Bilprevda | Skeletal-related events in advanced malignancies and giant cell tumor of bone | RANKL inhibitor | Henlius (Europe) and Shanghai Henlius Biotech (US) | 8/29/25 (FDA)
July 2025 (EMA positive opinion) |
FDA Approvals | |||||
Generic Name | Brand Name | Tumor Typea | MOA/Drug Class | Manufacturer | Approval |
Carboplatin | Kyxata™ | Ovarian | Chemotherapy | Avyxa Holdings | 8/8/25 |
Dasatinib | Phyrago™ | Ph+ CML, Ph+ ALL | Kinase inhibitor | Handa Therapeutics | 8/1/25 |
Denosumab-kyqqb | Aukelso | Skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy | RANKL inhibitor | Biocon Biologics | 9/16/25 |
Denosumab-qbdeb | Xtrenbo | Skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy | RANKL inhibitor | Gedeon Richter and Hikma Pharmaceutical | 9/16/25 |
Dordaviprone | Modeyso | Diffuse midline glioma | Protease activator | Jazz Pharmaceuticals | 8/6/25c |
Gemcitabine intravesical system | Inlexzo | Bladder | Nucleoside analog | Janssen Biotech | 9/9/25 |
Imlunestrant | Inluriyo | Breast | ER antagonist | Eli Lilly | 9/25/25 |
Lazertinib mesylate | Lazcluze | NSCLC | EGFR inhibitor | Janssen Biotech | 8/14/25 |
Leuprolide mesylate | Camcevi® | Prostate cancer | GnRH agonist | Foresee Pharmaceuticals | 8/25/25 |
Linvoseltamab-gcptd | Lynozyfic™ | Multiple myeloma | Bispecific BCMA-directed CD3 T-cell engager | Regeneron Pharmaceuticals | 7/2/25c |
Pembrolizumabd | Keytruda | Hodgkin lymphoma; primary mediastinal large B-cell lymphoma | PD-1 inhibitor | Merck | 7/24/25 |
Pembrolizumab and berahyaluronidase alfa-pmphd | Keytruda Qlex | Melanoma, NSCLC, MPM, HNSCC, urothelial, MSI-H or dMMR, gastric, esophageal, cervical, HCC, biliary tract, Merkel cell carcinoma, RCC, endometrial carcinoma, cutaneous SCC, triple-negative breast | PD-1 inhibitor and endoglycosidase | Merck | 9/19/25 |
Pembrolizumab and berahyaluronidase alfa-pmphd | Keytruda Qlex | Solid tumors (TMB-H) | PD-1 inhibitor and endoglycosidase | Merck | 9/19/25c |
Selumetinib sulfate | Koselugo® | Plexiform neurofibroma (age 1 year and older) | MEK inhibitor | AstraZeneca | 9/10/25 |
Sunvozertinib | Zegfrovy | NSCLC | EGFR inhibitor | Dizal Jiangsu | 7/2/25c |
Zongertinib | Hernexeos | NSCLC | HER2 inhibitor | Boehringer Ingelheim | 8/8/25d |
EMA Approvals | |||||
Generic Name | Brand Name | Tumor Typea | MOA/Drug Class | Manufacturer | Positive Opinion |
Denosumabb | Degevma | Skeletal-related events and giant cell tumor of bone | RANKL inhibitor | Teva Pharmaceuticals | September 2025 |
Denosumabb | Xbonzy | Skeletal-related events and giant cell tumor of bone | RANKL inhibitor | Reddy Holding | September 2025 |
Denosumabb | Zvogra® | Skeletal-related events and giant cell tumor of bone | RANKL inhibitor | Stada Arzneimittel | September 2025 |
Mosunetuzumab-axgbd | Lunsumio™ | Follicular lymphoma | Bispecific antibody | Roche | September 2025e |
Pembrolizumabd | Keytruda® | HNSCC | PD-1 inhibitor | Merck Sharp & Dohme | September 2025 |
Pembrolizumabd (SC formulation) | Keytruda | Melanoma, NSCLC, MPM, HNSCC, Hodgkin lymphoma, urothelial, RCC, MSI-H or dMMR, colorectal, esophageal, triple-negative breast, endometrial, cervical, gastric or GEJ adenocarcinoma, biliary tract carcinoma | PD-1 inhibitor | Merck Sharp & Dohme | September 2025 |
Selumetinib sulfate | Koselugo | Plexiform neurofibroma (adults) | MEK inhibitor | AstraZeneca | September 2025e |
Tislelizumabd | Tevimbra® | NSCLC | PD-1 inhibitor | BeOne Medicines Ireland | July 2025 |
Vimseltinib | Romvimza™ | Tenosynovial giant cell tumor | CSF1R inhibitor | Deciphera Pharmaceuticals | July 2025 |
Vorasidenib | Voranigo | Astrocytoma or oligodendroglioma | IDH inhibitor | Les Laboratoires Servier | July 2025 |
aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.
bBiosimilar.
cAccelerated approval.
dBiologic.
eConditional marketing authorization.
ALL, acute lymphocytic leukemia; BCMA, B-cell maturation antigen; CD3, cluster of differentiation 3; CML, chronic myeloid leukemia; CSF1R, colony stimulating factor 1 receptor; dMMR, mismatch repair deficient; EGFR, epidermal growth factor receptor; EMA, European Medicines Agency; ER, estrogen receptor; FDA, US Food and Drug Administration; GEJ, gastroesophageal junction; GnRH, gonadotropin releasing hormone; HCC, hepatocellular carcinoma; HER2, human epidermal growth factor receptor 2; HNSCC, head and neck squamous cell carcinoma; IDH, isocitrate dehydrogenase; MEK, mitogen-activated protein kinase kinase; MOA, mechanism of action; MPM, malignant pleural mesothelioma; MSI-H, microsatellite instability-high; NSCLC, non-small cell lung cancer; PD-1, programmed cell death protein 1; Ph+, Philadelphia chromosome-positive; RANKL, receptor activator of nuclear factor kappa beta; RCC, renal cell carcinoma; SC, subcutaneous; SCC, squamous cell carcinoma; TBM-H, tumor mutational burden-high.
Sources:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
