Sofetabart mipitecan receives US FDA Breakthrough Therapy designation for the treatment of certain patients with platinum-resistant ovarian cancer
“We are pleased the FDA has granted Breakthrough Therapy designation for sofetabart mipitecan, reflecting the significant unmet need in platinum-resistant ovarian cancer and the promising initial results shown in our Phase 1 study,” said Jacob Van Naarden, executive vice president, and president of Lilly Oncology and head of corporate business development. “Building on compelling results generated to date, we’ve initiated our Phase 3 FRAmework-01 trial with the goal of bringing a potential therapeutic option to patients with advanced ovarian cancer, across all levels of folate receptor expression.”
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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.