Current Edition

FDA Attempting to Address Unmet Needs for Patients with Brain Metastases

Molly Fellin Spence of Clarivate discusses the FDA’s efforts towards advancing the development of products for CNS metastases, where effective treatments and clinical trials are lacking. A March public workshop was held to identify how to advance the development of effective products. The FDA identified uncertainty in optimal clinical trial endpoints and study designs for evaluating products as a key impediment and encouraged panellists to rethink future trial designs.