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.”
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