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/Drug Class |
Manufacturer |
Approval |
Binimetinib |
Mektovi® |
NSCLC |
MEK inhibitor |
Array Biopharma |
3/12/25 |
Brentuximab vedotinb |
Adcetris® |
LBCL |
ADC |
Pfizer |
2/11/25d |
Cabozantinib |
Cabometyx® |
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 |
Conexxence® |
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 |
Romvimza™ |
TGCT |
CSF1R inhibitor |
Deciphera Pharmaceuticals |
2/14/25 |
EMA Approvals |
|||||
Generic Name |
Brand Name |
Tumor Typea |
MOA/Drug Class |
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. |
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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
