(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
(IN BRIEF) The European Commission has approved AstraZeneca’s Imfinzi (durvalumab) combined with gemcitabine and cisplatin as neoadjuvant therapy, followed by Imfinzi adjuvant monotherapy, for adults with resectable muscle-invasive bladder cancer. This approval is anchored in NIAGARA Phase III trial data … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged adjuvant monotherapy, AstraZeneca, cisplatin, curative intent, Dave Fredrickson, durvalumab, ESMO, European Commission, event-free survival, gemcitabine, Imfinzi, immunotherapy, MIBC, Michiel Van der Heijden, muscle-invasive bladder cancer, neoadjuvant chemotherapy, New England Journal of Medicine, NIAGARA Phase III, NMIBC, overall survival, radical cystectomy
(IN BRIEF) The POTOMAC Phase III trial results show that adding Imfinzi to standard BCG induction and maintenance therapy improves disease-free survival (DFS) for patients with high-risk non-muscle-invasive bladder cancer (NMIBC). The combination demonstrated significant benefits over BCG alone, with … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged AstraZeneca, Bacillus Calmette-Guérin, BCG, bladder cancer, cancer treatment, clinical trial, Cristian Massacesi, disease progression, disease-free survival, durvalumab, high-risk bladder cancer, Imfinzi, immunotherapy, Maria De Santis, NMIBC, non-muscle-invasive bladder cancer, Phase III Trial, POTOMAC
(IN BRIEF) The MATTERHORN Phase III trial has demonstrated that a perioperative regimen combining AstraZeneca’s Imfinzi (durvalumab) with FLOT chemotherapy significantly improves event-free survival in patients with resectable gastric and gastroesophageal junction cancers compared to standard chemotherapy alone. Interim findings … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged adjuvant, AstraZeneca, clinical trial, Cristian Massacesi, durvalumab, early-stage, EFS, event-free survival, FLOT chemotherapy, gastric cancer, gastroesophageal junction, GEJ cancers, global, Imfinzi, immunotherapy, locally advanced, MATTERHORN, Memorial Sloan Kettering, neoadjuvant, OS, overall survival, pathologic complete response, PCR, Phase III Trial, randomized, resectable, safety profile, tumor regression, Yelena Y. Janjigian
(IN BRIEF) AstraZeneca’s Imfinzi (durvalumab) has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for approval as a monotherapy to treat limited-stage small cell lung cancer (LS-SCLC) in patients whose disease … Read the full press release
Posted in Business, European Union, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged ADRIATIC Phase III trial, AstraZeneca, CHMP, disease progression, durvalumab, EMA, European Medicines Agency, hazard ratio, Imfinzi, immunotherapy, limited-stage small cell lung cancer, LS-SCLC, monotherapy, overall survival, platinum-based chemoradiation therapy, progression-free survival, regulatory review, safety profile, Small cell lung cancer, Suresh Senan, survival outcomes, Susan Galbraith, The New England Journal of Medicine, treatment approval
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