European Commission Approves ORSERDU in Patients with ER+, HER2-, ESR1-mutated Locally Advanced or Metastatic Breast Cancer
“We have long known that patients living with metastatic breast cancer need effective and tolerable options which treat their disease while enabling them to focus on the things that matter to them,” said Elcin Barker Ergun, CEO of the Menarini Group. “We are proud of delivering a new breast cancer treatment that offers efficacy in a once-daily pill and represents the first innovation in endocrine therapy in nearly two decades; we are also incredibly grateful for the support of the oncology researchers and all the patients who participated in the clinical studies that made today’s achievement possible.”
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“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.