Q4 2025: 7 FDA Decisions to Watch in Oncology

With the end of the year creeping closer, Targeted Oncology is bringing you the Prescripton Drug User Fee Act (PDUFA) target action dates in oncology that you need to be aware of coming in the last quarter of 2025. Some novel agents seek to change the treatment landscape of hard-to-treat cancers, while other agents seek expanded approval in new indications.

Cemiplimab in Cutaneous Squamous Cell Carcinoma

Adjuvant treatment with cemiplimab (Libtayo) elicited a statistically significant and clinically meaningful improvement in the primary end point of disease-free survival among patients with high-risk cutaneous squamous cell carcinoma after surgery, according to findings from the pivotal phase 3 C-POST trial (NCT03969004).

PDUFA Target Action Date: October 2025

Lurbinectedin/Atezolizumab in Extensive-Stage Small Cell Lung Cancer

The FDA granted priority review to the supplemental new drug application (sNDA) of lurbinectedin (Zepzelca) and atezolizumab (Tecentriq) as a first-line maintenance therapy in patients with extensive-stage small cell lung cancer, supported by data from the phase 3 IMforte study.

PDUFA Target Action Date: October 7, 2025

Belantamab Mafodotin in Multiple Myeloma

The biologics license application (BLA) of belantamab mafodotin (Blenrep) in patients with relapsed/refractory multiple myeloma had an initial PDUFA target action date of July 23, 2025, but was delayed to give the FDA more time to review the application. In July, the EU approved the agent, but the FDA’s Oncologic Drugs Advisory Committee also voted benefits of belantamab mafodotin did not outeweigh the risks.

PDUFA Target Action Date: October 23, 2025

Revumenib in Acute Myeloid Leukemia

In June 2025, the FDA granted priority review to the sNDA of revumenib (Revuforj) in relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). In November 2024, the FDA approved revumenib in KMT2A-rearranged acute leukemia.

PDUFA Target Action Date: October 25, 2025

Epcoritamab in Follicular Lymphoma

In July, the FDA granted priority review to the supplemental BLA (sBLA) of epcoritamab (Epkinly) plus rituximab (Rituxan) and lenalidomide (Revlimid) for the treatment of patients with follicular lymphoma following at least 1 prior systemic therapy. In June 2024, the FDA approved epcoritamab for the treatment of follicular lymphoma following 2 or more prior lines of therapy, making it the first subcutaneously delivered bispecific antibody in the intent-to-treat population.

PDUFA Target Action Date: November 30, 2025

Ziftomenib in Acute Myeloid Leukemia

The FDA granted priority review to the NDA of ziftomenib (KO-539) in NPM1-mutant AML. Data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting showed that single-agent ziftomenib demonstrated clinically meaningful, minimal residual disease-negative responses in patients with heavily pretreated, relapsed/refractory NPM1-mutant AML, which met the primary phase 2 end point of the phase 1b/2 KOMET-001 trial (NCT04067336).

PDUFA Target Action Date: November 30, 2025

Liso-Cel in Marginal Zone Lymphoma

In August, the FDA granted priority review to the sBLAof lisocabtagene maraleucel (liso-cel; Breyanzi) for the treatment of marginal zone lymphoma (MZL) following at least 2 prior lines of systemic therapy. The CD19-directed CAR T-cell therapy is already indicated for the treatment of diffuse large B-cell lymphoma.

PDUFA Target Action Date: December 5, 2025