(IN BRIEF) AstraZeneca has received approval from the European Commission for the use of Imfinzi (durvalumab) in combination with FLOT chemotherapy as a perioperative treatment for adults with resectable early-stage and locally advanced gastric and gastroesophageal junction cancers. The approval … Read the full press release
Posted in Business, European Union, Financial, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged AstraZeneca, AstraZeneca Expands Oncology Portfolio as EU Approves Imfinzi-Based Regimen for Early Gastric and GEJ Cancer, cancer immunotherapy approval, Committee for Medicinal Products for Human Use, Dave Fredrickson, durvalumab, EU cancer treatment authorization, European Commission, event-free survival, FLOT chemotherapy, Gastric Cancer Treatment, gastroesophageal junction cancer, Imfinzi, immunotherapy oncology, Josep Tabernero, MATTERHORN trial, MATTERHORN Trial Results Lead to EU Approval of Imfinzi Immunotherapy for Early-Stage Gastric Cancer Treatment, oncology clinical trials, overall survival, Vall d'Hebron University Hospital, Vall d’Hebron Institute of Oncology
(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
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
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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