USA – FDA drafts recommendations for studying cancer drugs in patients with CNS metastases

The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing recommendations to drugmakers on evaluating cancer drugs in patients with central nervous system (CNS) metastases.
 
FDA says the guidance is meant to inform clinical trial designs to support product labeling that describes antitumor activity of drugs or biologics in patients with CNS metastases from solid tumors originating in other parts of the body.
 
« There are few effective treatments for patients with central nervous system (CNS) metastases – a type of cancer that has spread from the original tumor to the CNS and is associated with a higher risk of death. In addition, there are also few clinical trials testing therapies for CNS metastases. More attention is warranted to address this unmet medical need,” said Richard Pazdur, director of FDA’s Oncology Center of Excellence…