Federal Register Notice: FDA is making available a draft guidance for industry entitled Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. It is the first in a series of guidances that will provide recommendations to sponsors on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in NDAs, BLAs, or supplemental applications. Sponsors are encouraged to use this draft guidance to design cancer clinical trials and to discuss protocols with the agency. This draft guidance provides background information and discusses general regulatory principles. The subsequent guidance will focus on endpoints for specific cancer types (e.g., lung cancer, colon cancer) to support drug approval or labeling claims. To download this guidance, click here. To view this notice, click here.
