FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation for B7-H3 CAR T-cell therapy for incurable pediatric brain tumors
“It’s gratifying to see another important benchmark reached in our work to combat pediatric brain cancer,” said Dr. Jeff Sperring, Chief Executive Officer at Seattle Children’s. “Our research is the foundation of progress to bring potential therapies to kids as fast as we can – and we’re excited about the possibilities afforded by this designation.”
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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.