FDA issues draft guidance on NSCLC endpoints

FDA issued draft guidance stating that the agency considers overall survival (OS) to be the standard clinical benefit endpoint that should be used to establish efficacy of treatments for advanced and metastatic non-small cell lung cancer (NSCLC). However, the agency said other endpoints, including progression-free survival (PFS), can be considered for regulatory decisions based on the population and the compound's risk-benefit profile. FDA said the observed magnitude of effect for PFS should be "substantial and robust" because of the subjectivity in the measurement of PFS assessments. ...