(IN BRIEF) The FDA has accepted AstraZeneca’s sBLA for Imfinzi as a perioperative immunotherapy regimen in resectable early‑stage and locally advanced gastric and GEJ cancers, granting Priority Review with a decision expected in Q4 2025. The application leverages MATTERHORN Phase III data … Read the full press release
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Tagged 2025 decision, adjuvant, AstraZeneca, breakthrough therapy designation, clinical paradigm shift, durvalumab, early-stage, EFS hazard ratio, event-free survival, FDA priority review, FLOT chemotherapy, gastric cancer, gastroesophageal junction cancer, high unmet need, Imfinzi, Levi Garraway, locally advanced, MATTERHORN Phase III, neoadjuvant, overall survival, Perioperative Immunotherapy, resectable, sBLA, Susan Galbraith
(PRESS RELEASE) CAMBRIDGE, 22-May-2020 — /EuropaWire/ — Enhertu, jointly developed by British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca and the second-largest pharmaceutical company in Japan Daiichi Sankyo (Daiichi Sankyo Company, Limited), has just been granted Orphan Drug Designation (ODD) in … Read the full press release
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