Bexmarilimab to advance into registrational Ph 2/3 study in 1L HR-MDS after positive meeting with the FDA
“We are extremely encouraged by the collaborative and highly productive dialogue with the FDA, which provided a clear and actionable path for the clinical development of bexmarilimab in frontline HR-MDS, an area of profound unmet medical need,” said Dr. Juho Jalkanen, Chief Executive Officer of Faron. “The agency’s guidance has endorsed a direct route towards accelerated approval using Complete Response (CR) + CR equivalent (CReq) per International Working Group (IWG) 2023 criteria as a co-primary endpoint with Overall Survival (OS). This is a significant step forward in our mission to provide a potentially transformative new treatment option to patients and represents a major regulatory de-risking milestone, as we are now only one study away from getting bexmarilimab approved for the benefit of HR MDS patients.”
Share:
More News
“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.