The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved 39 new or expanded indications for previously approved agents and 4 new oncology agents in the first quarter (Q1) of 2025. The approvals included approximately 14 solid tumor types and 8 hematologic malignancies. Approximately three-quarters of the approvals were for biologics or biosimilars; there were 22 biologics approved, and 7 biosimilars approved, 3 of which were new agents. There were 4 approvals by both the FDA and the EMA, including 1 new agent (datopotamab deruxtecan-dlnk; Datroway®; Daiichi Sankyo) for treatment of breast cancer.
Additional highlights from the first quarter of 2025
- Cabozantinib (Cabometyx®; Exelixis) became the first FDA-approved systemic therapy for treatment of neuroendocrine tumors regardless of primary tumor site, grade, somatostatin receptor expression, and functional status
- Six denosumab biosimilars were approved for supportive care
- Six products that previously received accelerated approval gained full approval by the FDA
- Acalabrutinib (Calquence®; AstraZeneca) as monotherapy for the treatment of mantle cell lymphoma
- Binimetinib (Mektovi®; Array Biopharma) approved in combination with encorafenib (Braftovi®; Array Biopharma) for treatment of non-small cell lung cancer
- Dabrafenib mesylate (Tafinlar®; Novartis) for treatment of melanoma
- Pembrolizumab (Keytruda®; Merck) for treatment of human epidermal growth factor receptor 2-positive gastric or gastroesophageal junction adenocarcinoma, in combination with trastuzumab and chemotherapy
- Trametinib dimethyl sulfoxide (Mekinist®; Novartis) for treatment of melanoma
- The most common molecular targets were Bruton tyrosine kinase (4 approvals), mitogen-activated extracellular signal-regulated kinase (3 approvals), programmed cell death protein 1 (PD-1; 3 approvals), and PD-1 ligand 1 (3 approvals)
- Two companion diagnostics were approved by the FDA
- The therascreen KRAS RGQ PCR Kit (QIAGEN GmbH) as a companion diagnostic device to identify patients with colorectal cancer whose tumors harbor KRAS G12C mutations and may be eligible for sotorasib (Lumakras®; Amgen) with panitumumab (Vectibix®; Amgen)
- FoundationOne®CDx companion diagnostic for tovorafenib (Ojemda™) to treat the most common form of childhood brain tumor in pediatric patients
- Two diagnostics were approved for prostate cancer diagnosis
- TLX007-CDx (Gozellix®; Telix), a prostate-specific membrane antigen positron emission tomography imaging agent
- QP-Prostate® CAD (Quibim)
The tables below summarize key Q1 2025 oncology approvals. Treatments in bold font represent new agent approvals by each agency; 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 |
Acalabrutinibb | Calquence® | Mantle cell lymphoma (combination therapy) | BTK inhibitor | AstraZeneca | 1/16/25 (FDA) / March 2024c (EMA) |
Acalabrutinibb | Calquence | Mantle cell lymphoma (monotherapy) | BTK inhibitor | AstraZeneca | 1/16/25 (FDA) / February 2024c (EMA) |
Datopotamab deruxtecan-dlnkb | Datroway® | Breast cancer | Trop-2–directed ADC | Daiichi Sankyo | 1/17/25 (FDA) / January 2025 (EMA)c |
Trastuzumab deruxtecanb | Enhertu® | Breast cancer | HER2-directed ADC | AstraZeneca | 1/27/25 (FDA) / February 2025 (EMA)c |
FDA Approvals | |||||
Generic Name | Brand Name | Tumor Typea | MOA | Manufacturer | Approval |
Binimetinib | Mektovi® | NSCLC | MEK inhibitor | Array Biopharma | 3/12/25 |
Brentuximab vedotinb | Adcetris® | LBCL | ADC | Pfizer | 2/11/25d |
Cabozantinib | Cabom | pNET and epNET | Tyrosine kinase inhibitor | Exelixis | 3/26/25 |
Dabrafenib mesylate | Tafinlar® | Melanoma | BRAF inhibitor | Novartis | 3/7/25 |
Denosumabe | Osenvelt® | Skeletal-related events in advanced malignancies and giant cell bone tumor; hypercalcemia of malignancy | RANKL inhibitor | Celltrion | 2/28/25 |
Denosumabe | Stobodo® | Prostate cancer and breast cancer at high risk for fracture | RANKL inhibitor | Celltrion | 2/28/25 |
Denosumabe | Conexx | Prostate cancer and breast cancer at high risk for fracture | RANKL inhibitor | Fresenius Kabi USA | 3/25/25 |
Denosumabe | Bomyntra® | Skeletal-related events in multiple myeloma; giant cell tumor of bone; hypercalcemia of malignancy | RANKL inhibitor | Fresenius Kabi USA | 3/25/25 |
Durvalumabb | Imfinzi® | Bladder cancer | PD-L1 inhibitor | AstraZeneca | 3/28/25 |
Encorafenib | Braftovi® | NSCLC | BRAF inhibitor | Array Biopharma | 3/12/25 |
Lutetium Lu 177 vipivotide tetraxetan | Pluvicto® | Prostate cancer | Radiopharmaceutical | Novartis | 3/28/25 |
Mirdametinib | Gomekli™ | Neurofibromatosis type 1 tumors | MEK 1/2 inhibitor | SpringWorks Therapeutics | 2/11/25 |
Panitumumabb | Vectibix® | Colorectal cancer | EGFR antagonist | Amgen | 1/16/25 |
Pembrolizumabb | Keytruda® | Gastric or GEJ adenocarcinoma | PD-1 inhibitor | Merck | 3/19/25 |
Sotorasibb | Lumakras® | Colorectal cancer | KRAS G12C inhibitor | Amgen | 1/16/25 |
Tislelizumabb | Tevimbra® | Esophageal squamous cell carcinoma | PD-L1 inhibitor | BeOne Medicines | 3/4/25 |
Trametinib dimethyl sulfoxide | Mekinist® | Melanoma | MEK inhibitor | Novartis | 3/7/25 |
Treosulfan | Grafapex™ | AML; MDS | Alkylating agent | Medac GmbH | 1/21/25 |
Vimseltinibb | Romv | TGCT | CSF1R inhibitor | Deciphera Pharmaceuticals | 4/25/24 |
EMA Approvals | |||||
Generic Name | Brand Name | Tumor Typea | MOA | Manufacturer | Approval |
Bosutinib | Bosulif® | Ph+ CML | BCR-ABL inhibitor | Pfizer | March 2025c |
Daratumumabb | Darzalex® | Multiple myeloma | Cytolytic antibody | Janssen-Cilag | February 2025f |
Denosumabe | Jubereq® | Skeletal-related events in advanced malignancies and giant cell bone tumor | RANKL inhibitor | Accord Healthcare | March 2025c |
Denosumabe | Osvyrti® | Prostate cancer at increased risk of fractures | RANKL inhibitor | Accord Healthcare | March 2025c |
Durvalumabb | Imfinzi® | SCLC | PD-L1 inhibitor | AstraZeneca | January 2025c |
Durvalumabb | Imfinzi | NSCLC | PD-L1 inhibitor | AstraZeneca | January 2025c |
Glofitamabb | Columvi™ | DLBCL | Bispecific antibody | Roche | February 2025c |
Ipilimumabb | Yervoy® | HCC | CTLA-4 inhibitor | Bristol Myers Squibb | January 2025c |
Linvoseltamabb | Lynozyfic® | Multiple myeloma | Bispecific antibody | Regeneron | February 2025f |
Lisocabtagene maraleucelb | Breyanzi® | Follicular lymphoma | CAR T-cell therapy | Bristol Myers Squibb | January 2025c |
Nivolumabb | Opdivo® | HCC | PD-1 inhibitor | Bristol Myers Squibb | January 2025c |
Nivolumabb | Opdivo | NSCLC | PD-1 inhibitor | Bristol Myers Squibb | March 2025c |
Pegfilgrastime | Dyrupeg™ | Neutropenia | G-CSF | CuraTeQ Biologics | January 2025c |
Pirtobrutinib | Jaypirca® | CLL | BTK inhibitor | Eli Lilly | February 2025c |
Tislelizumabb | Tevimbra® | SCLC | PD-L1 inhibitor | BeOne Medicines Ireland | March 2025c |
Tisotumab vedotinb | Tivdak® | Cervical cancer | ADC | Pfizer | January 2025c |
aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.bBiologic.cPositive opinion.dAccelerated approval.eBiosimilar.fConditional marketing authorization.ADC, antibody-drug conjugate; AML, acute myeloid leukemia; BCR-ABL, breakpoint cluster region-Abelson murine leukemia; BRAF, v-raf murine sarcoma viral oncogene homolog B1; BTK, Bruton tyrosine kinase; CAR, chimeric antigen receptor; CLL, chronic lymphocytic leukemia; CML, chronic myelogenous leukemia; CSF1R, colony-stimulating factor 1 receptor; CTLA-4, cytotoxic T-lymphocyte-associated antigen 4; DLBCL, diffuse large B-cell lymphoma; EGFR, epidermal growth factor receptor; EMA, European Medicines Agency; epNET, extra-pancreatic neuroendocrine tumor; FDA, US Food and Drug Administration; G-CSF, granulocyte colony-stimulating factor; GEJ, gastroesophageal junction; HCC, hepatocellular carcinoma; HER2, human epidermal growth factor receptor 2; LBCL, large B-cell lymphoma; MDS, myelodysplastic syndrome; MEK, mitogen-activated protein kinase kinase; MOA, mechanism of action; NSCLC, non-small cell lung cancer; PD-1, programmed cell death protein 1; PD-L1, PD-1 ligand 1; Ph+, Philadelphia chromosome-positive; pNET, pancreatic neuroendocrine tumor; RANKL, receptor activator of nuclear factor kappa B ligand; SCLC, small cell lung cancer; TGCT, tenosynovial giant cell tumor; Trop-2, trophoblast cell surface antigen 2. | |||||
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.foundationmedicine.com/press-release/fda-approval-foundationone-cdx-ojemda
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761232Orig1s000lbl.pdf
https://www.telixpharma.com/news-views/fda-approves-new-prostate-cancer-imaging-agent-gozellix
