US FDA Type C Statistical Methods Meeting Granted to Review 2.5-Year OS Data for OST-HER2 in Metastatic Osteosarcoma
“We expect this Type C Statistics Methods Meeting with FDA to focus on the appropriateness of using pooled non-concurrent published historical control data, as compared with concurrent natural history data generated via OST-400, to evaluate the clinical efficacy data generated from the OST-HER2 Metastatic Osteosarcoma Trial,” said Dr. Craig Eagle, Chief Medical Advisor and member of the OS Therapies Board of Directors. “We are heartened that overall survival at the 2.5-year timepoint remained unchanged from the 2-year timepoint. We look forward to the interim 3-year overall survival data in early September 2026, that will allow for decisions on our pending Regenerative Medicine Advanced Therapy (RMAT) designation submission, FDA Rolling Review and Commissioner’s National Priority Review Voucher more rapidly to facilitate a potential Biologics License Application under the Accelerated Approval Program by year end 2026.”
Share:
More News
“These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel
“The collaboration with Ratio represents an exciting opportunity to explore the potential of novel radiopharmaceutical approaches designed to address the complexity and heterogeneity of cancer,” said Ben Hickey, President of RayzeBio. “The combination of our respective technologies and complementary development expertise creates a strong foundation for generating a novel differentiated
“We believe these results mark a potentially important step forward in the treatment of EGFR exon 20 insertion mutation-positive non-small cell lung cancer,” said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. “To address the unmet medical needs of patients and their families, we will continue working closely with
“Recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer, including those with actionable mutations,” stated Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude. “Dual KAT6A/B inhibitors, however, demonstrated overlapping toxicities with current backbone therapies that may limit the utility in earlier lines