New FDA Guidance on Lung Cancer Drugs Allows More Options in Outcome Measures

Clinical trials to test non-small cell lung cancer treatments that didn’t use the gold standard endpoint of overall survival may be used to support drug approval because the risk-benefit profile still may indicate that the drug is safe and effective, the Food and Drug Administration said in a final guidance released April 22.

The guidance, “Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics,” provided recommendations to applicants on endpoints for cancer clinical trials submitted to the FDA to support effectiveness claims in new drug applications, biologics license applications or supplemental applications for non-small cell ...