Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Non-Small Cell Lung 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 for the treatment of non- small cell lung cancer. This guidance focuses on endpoints specifically for lung cancer trials to support drug approval or labeling claims. This guidance should speed the development and improve the quality of protocols submitted to FDA to support anticancer effectiveness claims. This guidance finalizes the draft guidance issued on June 17, 2011.