Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics." This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in new drug applications, biologics license applications, or supplemental applications. Applicants are encouraged to use this guidance to design cancer clinical trials and to discuss protocols with the agency. This guidance provides background information and discusses general regulatory principles. Additional companion guidances will follow and will focus on endpoints for specific cancer types (e.g., lung cancer, colon cancer) to support drug approval or labeling claims. This guidance, and the subsequent indication-specific guidances, should speed the development and improve the quality of protocols submitted to the agency to support anticancer effectiveness claims.