DATROWAY® Type II Variation Application Validated in the EU for Patients with 1L Metastatic, IO-ineligible TNBC
“DATROWAY has shown the potential to replace traditional chemotherapy and improve survival for patients with metastatic triple negative breast cancer, the most aggressive type of breast cancer with one of the worst prognoses,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “This EMA validation represents the potential for a second indication for DATROWAY in breast cancer and another step forward in the approval process in 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.