(IN BRIEF) Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets) has received accelerated approval in China for patients with advanced NSCLC carrying HER2 mutations who have progressed after prior therapy. The approval is supported by Beamion-LUNG 1 data, which showed a 71% objective … Read the full press release
Posted in Business, Financial, Germany, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged AACR 2025, Beamion-LUNG 1, Beamion-LUNG 2, Boehringer Ingelheim, breakthrough therapy designation, CHINA, HER2 mutations, HERNEXEOS, New England Journal of Medicine, NMPA approval, non-small cell lung cancer, NSCLC, oncology, partnership, Shashank Deshpande, targeted therapy, tyrosine kinase inhibitor, Wu Yilong, zongertinib
(IN BRIEF) Final overall survival results from AstraZeneca’s FLAURA2 Phase III trial confirm that combining Tagrisso with chemotherapy significantly improves survival for patients with first-line advanced EGFR-mutated NSCLC. The data reinforce Tagrisso as the foundational therapy in this setting, building … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged ADAURA trial, ADAURA2, adjuvant therapy, AstraZeneca, cancer survival, chemotherapy, EGFRm NSCLC, EMA, FDA, FLAURA2 trial, global clinical trial, LAURA trial, lung cancer treatment, NeoADAURA, non-small cell lung cancer, oncology, osimertinib, overall survival, Pasi A. Jänne, pemetrexed, platinum-based treatment, progression-free survival, Susan Galbraith, Tagrisso, targeted therapy
(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted by the U.S. FDA for treating advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have previously received systemic therapies. The … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged advanced NSCLC, antibody-drug conjugate, AstraZeneca, Biologics License Application, BLA, breakthrough therapy designation, Daiichi Sankyo, datopotamab deruxtecan, drug approval, EGFR-mutated, EGFR-tyrosine kinase inhibitors, FDA, metastatic NSCLC, non-small cell lung cancer, NSCLC, objective response rate, oncology, partnership, Phase III Trials, Priority Review, safety profile, systemic therapies, TROP2-directed, TROPION-Lung01, TROPION-Lung05, TROPION-Lung14, TROPION-Lung15
Application is being reviewed under the US FDA’s Real-Time Oncology Review pilot programme Based on results of the Phase III IMpower010 study, presented at ASCO, that showed adjuvant Tecentriq improved disease-free survival by more than one-third in PD-L1-positive early-stage lung cancer, compared with … Read the full press release
Posted in Healthcare, Marketing, News, Pharma & Biotech, Switzerland
Tagged atezolizumab, Cancer Immunotherapy, chemotherapy, FDA, Levi Garraway, lung cancer, non-small cell lung cancer, NSCLC, Real-Time Oncology Review, Roche, sBLA, supplemental Biologics License Application, Tecentriq®, treatment, tumours
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