OS Therapies Announces Successful Type C Meeting with US FDA Regarding Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma

FDA confirmed that data from single-arm studies in rare diseases, such as in ultra-rare deadly pediatric cancer osteosarcoma, could support a Biologics Licensing Application (BLA) under Accelerated Approval Program pathway, as stated in FDA guidance documentsFDA proposed confirmatory study design include additional osteosarcoma disease settings such as prevention of recurrence following primary tumor resection, where a randomized controlled study may be feasible and that the confirmatory study would have t ...