CHMP Positive Opinion for Trodelvy in Pre-Treated HR+/HER2- Metastatic Breast Cancer
“This positive opinion from the Committee confirms the clinical benefit and value of sacituzumab govitecan in pre-treated HR+/HER2- metastatic breast cancer and is a positive step toward bringing this treatment option to patients in Europe,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, in Madrid and Barcelona, Spain. “Too many people living with pre-treated HR+/HER2- metastatic breast cancer are without treatment options after their cancer progresses, and this positive opinion is a significant step forward for patients and their loved ones across Europe.”
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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.