The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved 54 new or expanded indications for previously approved agents (including 15 denosumab biosimilars) and only 2 new oncology agents in the fourth quarter of 2025. The approvals included approximately 13 solid tumor types and 8 hematologic malignancies. The majority of the approvals were for biologics or biosimilars; there were 15 biosimilar and 25 biologic approvals. There was 1 drug (a biologic) approved by both the FDA and the EMA, cemiplimab-rwlc, (Libtayo®; Regeneron) for treatment of cutaneous squamous cell carcinoma.
Additional highlights from the fourth quarter of 2025:
- Drug approvals encompassed 23 different modes of action; the most common were RANKL inhibitors (15 approvals, all denosumab biosimilars, 12 of which were “interchangeable” designation), PD-1 inhibitors (7 approvals), PD-L1–blocking antibodies (5 approvals), bispecifics (3 approvals), antibody-drug conjugates (3 approvals), and monoclonal antibodies (3 approvals)
- The tumor types with the most approvals were lung (7; non-small cell lung cancer [NSCLC] and small cell lung cancer [SCLC]), lymphomas (6; includes follicular, small lymphocytic, mantle cell, and marginal zone lymphomas), bladder cancer (4), breast cancer (3), colorectal cancer (3), and prostate cancer (3)
- FDA approvals for solid tumors included
- The first subcutaneous bispecific antibody therapy for EGFR-mutated NSCLC: amivantamab and hyaluronidase-lpuj (Rybrevant Faspro™; Johnson & Johnson)
- A HER2 inhibitor for NSCLC: sevabertinib (Hyrnuo®; Bayer)
- Lurbinectedin (Zepzelca®; Jazz Pharmaceuticals), for treatment of SCLC in combination with atezolizumab (Tecentriq®; Genentech) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza™; Genentech)
- Nivolumab and hyaluronidase-nvhy (Opdivo Qvantig™; Bristol Myers Squibb) for treatment of colorectal cancer following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
- Rucaparib (Rubraca®; pharma&) for treatment of prostate cancer
- FDA approvals for hematologic malignancies included
- A menin inhibitor for treatment of acute myeloid leukemia: ziftomenib (Komzifti™; Kura Oncology)
- Daratumumab and hyaluronidase-fihj (Darzalex Faspro®; Johnson & Johnson) for the treatment of light chain amyloidosis
- Pirtobrutinib (Jaypirca®; Eli Lilly and Company) for treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma
- Retifanlimab-dlwr (Zynyz®; Incyte) for treatment of Merkel cell carcinoma
- The FDA also approved 2 companion diagnostics
- The PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody and VENTANA® HER2 Dual ISH DNA Probe Cocktail (Roche) as companion diagnostic devices for selecting patients with HER2-positive (HER2 IHC3+ or ISH+) breast cancer who may be eligible for treatment with fam-trastuzumab deruxtecan-nxki (Enhertu®; Daiichi Sankyo)
- The Oncomine™ Dx Target Test (Life Technologies Corporation), to aid in detecting HER2 (ERBB2) TKD-activating mutations in patients with nonsquamous NSCLC who may be eligible for treatment with sevabertinib (Hyrnuo®; Bayer)
The tables below summarize key oncology approvals in Q4 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 |
| Cemiplimab-rwlcb | Libtayo® | Cutaneous SCC | PD-1 inhibitor | Regeneron | 10/8/25 (FDA) October 2025 (EMA) |
FDA Approvals | |||||
Generic Name | Brand Name | Tumor Typea | MOA/Drug Class | Manufacturer | Approval |
Abiraterone acetate; niraparib tosylate | Akeega® | Prostate | PARP inhibitor and CYP17 inhibitor | Johnson & Johnson | 12/12/25 |
Amivantamab and hyaluronidase-lpujb | Rybrevant Faspro™ | NSCLC | Bispecific antibody | Johnson & Johnson | 12/17/25 |
Atezolizumabb | Tecentriq® | SCLC | PD-L1–blocking antibody | Genentech | 10/2/25 |
Atezolizumab and hyaluronidase-tqjsb | Tecentriq Hybreza™ | SCLC | PD-L1–blocking antibody and endoglycosidase | Genentech | 10/2/25 |
Atezolizumab and hyaluronidase-tqjsb | Tecentriq Hybreza | Alveolar soft part sarcoma | PD-L1–blocking antibody and endoglycosidase | Genentech | 11/24/25 |
Belantamab mafodotin-blmfb | Blenrep | Multiple myeloma | Antibody-drug conjugate | GSK | 10/23/25 |
Daratumumab and hyaluronidase-fihjb | Darzalex Faspro® | Multiple myeloma | Monoclonal antibody and polysaccharide | Johnson & Johnson | 11/6/25 |
Daratumumab and hyaluronidase-fihjb | Darzalex Faspro | Light chain amyloidosis | Monoclonal antibody and polysaccharide | Johnson & Johnson | 11/19/25 |
Denosumab-bnhtc | Bomyntra® | Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy | RANKL inhibitor | Fresenius Kabi | 10/29/25 |
Denosumab-bnhtc | Conexxence® | To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture | RANKL inhibitor | Fresenius Kabi | 10/29/25 |
Denosumab-bmwoc | Stoboclo® | To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture | RANKL inhibitor | Celltrion | 10/29/25 |
Denosumab-bmwoc | Osenvelt® | Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy | RANKL inhibitor | Celltrion | 10/29/25 |
Denosumab-desud | Jubereq | Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy | RANKL inhibitor | Accord BioPharma | 10/29/25 |
Denosumab-desud | Osvyrti | To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture | RANKL inhibitor | Accord BioPharma | 10/29/25 |
Denosumab-dssbc | Ospomyv™ | To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture | RANKL inhibitor | Samsung Bioepis | 10/29/25 |
Denosumab-dssbc | Xbryk™ | Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy | RANKL inhibitor | Samsung Bioepis | 10/29/25 |
Denosumab-kyqqc | Bosaya™ | To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture | RANKL inhibitor | Biocon Biologics | 10/29/25 |
Denosumab-kyqqc | Aukelso™ | Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy | RANKL inhibitor | Biocon Biologics | 10/29/25 |
Denosumab-mobzd | Oziltus | Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy | RANKL inhibitor | Amneal Pharmaceuticals | 12/19/25 |
Denosumab-nxxpc | Bildyos® | To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture | RANKL inhibitor | Shanghai Henlius | 10/29/25 |
Denosumab-nxxpc | Bilprevda® | Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy | RANKL inhibitor | Shanghai Henlius | 10/29/25 |
Denosumab-qbdec | Enoby™ | To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture | RANKL inhibitor | Hikma Pharmaceuticals | 10/29/25 |
Denosumab-qbdec | Xtrenbo | Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy | RANKL inhibitor | Hikma Pharmaceuticals | 10/29/25 |
Durvalumabb | Imfinzi® | Gastric, GEJ | PD-L1–blocking antibody | AstraZeneca | 11/25/25 |
Enfortumab vedotin-efjvb | Padcev® | Bladder | Antibody-drug conjugate | Astellas Pharma | 11/21/25 |
Epcoritamab | Epkinly® | Follicular lymphoma | Bispecific antibody | Genmab | 11/18/25 |
Fam-trastuzumab deruxtecan-nxkib | Enhertu® | Breast | Antibody-drug conjugate | Daiichi Sankyo | 12/15/25 |
Lisocabtagene maraleucelb | Breyanzi™ | Marginal zone lymphoma | CAR T | Bristol Myers Squibb | 12/4/25 |
Lurbinectedin | Zepzelca® | SCLC | Alkylating drug | Jazz Pharmaceuticals | 10/2/25 |
Mosunetuzumab-axgbb | Lunsumio Velo™ | Follicular lymphoma | Bispecific antibody | Genentech | 12/19/25e |
Nivolumab and hyaluronidase-nvhyb | Opdivo Qvantig™ | Colorectal (following treatment with IV nivolumab and ipilimumab) | PD-1 inhibitor and endoglycosidase | Bristol Myers Squibb | 10/27/25 |
Nivolumab and hyaluronidase-nvhyb | Opdivo Qvantig™ | Colorectal (following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan) | PD-1 inhibitor and endoglycosidase | Bristol Myers Squibb | 10/27/25 |
Nivolumab and hyaluronidase-nvhyb | Opdivo Qvantig™ | Colorectal (pediatric ≥12 years) | PD-1 inhibitor and endoglycosidase | Bristol Myers Squibb | 11/24/25 |
Pegfilgrastime-unned | Armlupeg | Infections | G-CSF | Lupin | 11/28/25 |
Pembrolizumabb | Keytruda® | Bladder | PD-1 inhibitor | Merck | 11/21/25 |
Pembrolizumab and berahyaluronidase alfa-pmphb | Keytruda Qlex™ | Bladder | PD-1 inhibitor and endoglycosidase | Merck | 11/21/25 |
Pemetrexed | Axtle™ | NSCLC | Folate analog metabolic inhibitor | Avyxa Holdings | 10/3/25 |
Pertuzumab-dpzbc | Poherdy® | Breast | HER2/neu receptor antagonist | Shanghai Henlius | 11/13/25 |
Pirtobrutinib | Jaypirca® | CLL or SLL | BTK inhibitor | Eli Lilly and Company | 12/2/25 |
Retifanlimab-dlwrb | Zynyz® | Merkel cell carcinoma | PD-1 inhibitor | Incyte | 12/17/25 |
Revumenib | Refuforj® | AML | Menin inhibitor | Syndax | 10/24/25 |
Rucaparib | Rubraca® | Prostate | PARP inhibitor | pharma& | 12/17/25 |
Selumetinib | Koselugo® | Neurofibromatosis | MEK inhibitor | AstraZeneca | 11/19/25 |
Sevabertinib | Hyrnuo® | NSCLC | HER2 inhibitor | Bayer | 11/19/25 |
Ziftomenib | Komzifti™ | AML | Menin inhibitor | Kura Oncology | 11/13/25 |
EMA Approvals | |||||
Generic Name | Brand Name | Tumor Typea | MOA/Drug Class | Manufacturer | Positive Opinion |
Asciminib | Scemblix® | CML | TKI | Novartis | October 2025 |
Enzalutamide | Enzalutamide | Prostate | Androgen receptor inhibitor | Accord Healthcare | November 2025 |
Imlunestrant | Inluriyo™ | Breast | ER antagonist | Eli Lilly | November 2025 |
Lisocabtagene maraleucelb | Breyanzi™ | Mantle cell lymphoma | CAR T | Bristol Myers Squibb | October 2025 |
Nogapendekin alfa inbakiceptb | Anktiva® | Bladder | IL-15 receptor agonist | Serum Life Science Europe | December 2025 |
Selumetinib | Koselugo® | Plexiform neurofibroma (pediatric) | MEK inhibitor | AstraZeneca | November 2025 |
Sugemalimabb | Cejemly® | NSCLC | PD-L1– blocking antibody | CStone Pharmaceuticals | October 2025 |
Tafasitamabb | Minjuvi® | Follicular lymphoma | Monoclonal antibody | Incyte | November 2025 |
a Please see each product’s prescribing information and summary of product characteristics for full indications and labeling information.
b Biologic.
c Interchangeable biosimilar.
d Biosimilar.
e Accelerated approval.
AML, acute myeloid leukemia; BTK, Bruton tyrosine kinase inhibitor; CAR T, chimeric antigen receptor T-cell therapy; CLL, chronic lymphocytic leukemia; CML, chronic myeloid leukemia; CYP17A1, cytochrome P450 family 17 subfamily A member 1; EGFR, epidermal growth factor receptor; EMA, European Medicines Agency; ER, estrogen receptor; ERBB2, epidermal growth factor receptor 2 (HER2); FDA, US Food and Drug Administration; G-CSF, granulocyte colony-stimulating factor; GEJ, gastroesophageal junction; HER2, human epidermal growth factor receptor 2; IL-15, interleukin-15; MEK, Mitogen-activated protein kinase; MOA, mechanism of action; NSCLC, non-small cell lung cancer; PARP, poly(ADP-ribose) polymerase; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; RANKL, receptor activator of nuclear factor kappa-beta ligand; SCC, squamous cell carcinoma; SCLC, small cell lung cancer; SLL, small lymphocytic lymphoma; TKI, tyrosine kinase inhibitor.
Sources:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
