Durvalumab Receives Priority Review for Gastric/GEJ Cancers
Durvalumab has been granted FDA Priority Review for the treatment of resectable, early‑stage and locally advanced gastric and gastroesophageal junction cancers.
The U.S. Food and Drug Administration has granted Priority Review to durvalumab (Imfinzi®) for patients with resectable, early‑stage and locally advanced (Stage II‑IVA) gastric and gastroesophageal junction (GEJ) cancers. The decision follows data from the double‑blind, placebo‑controlled MATTERHORN trial (NCT04592913), which evaluated durvalumab combined with perioperative FLOT chemotherapy versus placebo. Interim analysis demonstrated a statistically significant improvement in event‑free survival (HR 0.71; P < 0.001) and a favorable overall‑survival trend (HR 0.78; P = 0.025). This priority review underscores the potential of a perioperative immunotherapy approach to transform care in this high‑risk population.
The priority review indicates a rapidly advancing clinical promise that could change the standard of care for early‑stage and locally advanced gastric/GEJ cancers, offering patients a new perioperative strategy to reduce recurrence and improve long‑term outcomes.
Evidence level: Állatkísérletes. Állatmodellben vizsgálták.
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