Patient-Reported Outcomes with Mirvetuximab vs Chemo in FORWARD I Study Reinforces Differentiated Tolerability Profile
“The data presented at ESMO continue to support mirvetuximab’s potential to displace single-agent chemotherapy in FRα-positive ovarian cancer and will serve as a guide as we seek to advance the broader development program,” said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. “With our biologics license application for mirvetuximab under Priority Review with FDA, we look forward to potentially bringing this novel therapy to patients later this year.”
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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.