FDA to meet on Orphan tissue-agnostic therapies

FDA said it will hold a public workshop on May 9 to discuss utilizing Orphan Drug designation for tissue-agnostic therapies: drugs and biologics that target a tumor’s specific genetic features rather than its tissue of origin. The agency will publish a schedule and additional background information on May 4.

FDA released guidance in December on developing tissue-agnostic therapies (see BioCentury Extra, Dec. 15, 2017)...