The Cellular, Tissue, and Gene Therapies Advisory Committee will review Replimune’s twice-rejected BLA for RP1 plus nivolumab in advanced melanoma.
News|Articles|May 4, 2026
April Roundup of FDA Approvals in Oncology: 2 Decisions to Know
Author(s)Kristi Rosa
Here is your cheat sheet to all oncology therapeutic options that were cleared or rejected by the FDA in April 2026.
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Below is your guide to all the oncologic options that were approved, rejected, or withdrawn by the FDA in April 2026. The regulatory roundup provides everything you need to know, right at your fingertips—all the topline data that supported the decisions and expert insights detailing clinical practice implications.
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The FDA’s CTGTAC voted that the data from the IGNYTE trial are evaluable and clinically meaningful for RP1/nivolumab in advanced cutaneous melanoma.
FDA has granted RMAT and fast track designations to celma-cel as a frontline consolidation in large B-cell lymphoma.
The FDA issued final guidances on performance status, washout periods, and laboratory values aimed at expanding oncology trial participation.
Laurence J. DiNardo, MD, FACS, discusses ctDNA testing in head and neck cancers, advancements in targeted therapies, and multidisciplinary collaboration.
Matthew Galsky, MD, discusses the FDA approval of perioperative pembrolizumab plus enfortumab vedotin in MIBC.
PRAME-directed therapies represent a novel approach in the treatment of advanced melanoma.
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