(IN BRIEF) GSK plc has received Orphan Drug Designation in Japan for its investigational antibody-drug conjugate risvutatug rezetecan (Ris-Rez) for the treatment of small-cell lung cancer, supported by early clinical data showing durable responses in patients with extensive-stage disease. SCLC, … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged antibody-drug conjugate, ARTEMIS-001, B7-H3, breakthrough therapy designation, clinical trials, colorectal cancer, EMA, ES SCLC, extensive stage SCLC, FDA, GSK, GSK advances investigational cancer therapy risvutatug rezetecan with sixth global designation supporting development in solid tumours, Hansoh Pharma, Japan Ministry of Health Labour and Welfare, lung cancer, oncology, orphan drug designation, Phase III Trial, PRIME designation, prostate cancer, Ris Rez, risvutatug rezetecan, SCLC, Small cell lung cancer
(IN BRIEF) GSK announced that its B7-H3-targeted antibody-drug conjugate GSK5764227 (GSK’227) has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of pulmonary neuroendocrine carcinoma, including small-cell lung cancer (SCLC). The designation is supported … Read the full press release
Posted in Business, Healthcare, Investment, Pharma & Biotech, Science, Technology, United Kingdom
Tagged ADC, antibody-drug conjugate, ARTEMIS-001, B7-H3, breakthrough therapy designation, cancer research, EMA, EMA Grants Orphan Drug Designation to GSK’s B7-H3 Antibody-Drug Conjugate for Pulmonary Neuroendocrine Carcinoma, FDA, GSK, GSK Strengthens Oncology Pipeline With EMA Orphan Drug Status for GSK’227 in Small-Cell Lung Cancer, GSK5764227, GSK’227, immuno-oncology, lung cancer, NEC, ODD, oncology, oncology pipeline, orphan drug designation, PRIME designation, pulmonary neuroendocrine carcinoma, relapsed or refractory, SCLC, Small cell lung cancer, solid tumours, targeted therapy
(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
(IN BRIEF) AstraZeneca announces positive outcomes from the ADRIATIC Phase III trial, revealing that its immunotherapy drug Imfinzi (durvalumab) demonstrated a significant improvement in overall survival (OS) and progression-free survival (PFS) among patients with limited-stage small cell lung cancer (LS-SCLC) … Read the full press release
(PRESS RELEASE) CAMBRIDGE, 20-Nov-2020 — /EuropaWire/ — AstraZeneca (LON: AZN), a global, science-led biopharmaceutical company, has announced the US Food and Drug Administration (FDA) approval of its Imfinzi (durvalumab) for an additional dosing option, a 1,500mg fixed dose every four … Read the full press release
Posted in Healthcare, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged bladder cancer, Dave Fredrickson, Imfinzi, Io, lung cancer, NSCLC, oncology, SCLC, Small cell lung cancer, Victoria M. Villaflor MD
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