Durvalumab plus enfortumab vedotin improved EFS and OS in MIBC and will be considered for FDA approval in the fourth quarter of 2026.
News|Articles|June 5, 2026
May 2026: FDA Oncology Actions at a Glance
Author(s)Targeted Oncology Staff
Fact checked by: Sabrina Serani
FDA greenlights eight May 2026 oncology approvals, debuting first PROTAC, expanding breast ADCs, and advancing biomarker-driven bladder cancer and rare blood cancers.
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May 2026 proved to be one of the most consequential months of the year for oncology regulators, with the FDA issuing 8 oncology and hematology approvals spanning breast cancer, bladder cancer, hematologic malignancies, and rare solid tumors. The month opened with a historic milestone—the first-ever FDA approval of a PROTAC (proteolysis-targeting chimera) in any indication—and closed with a novel antibody-drug conjugate for an ultra-rare blood cancer. Below is a glance at every key action from the month.
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