American Society of Clinical Oncology draft recommendations provide benchmarks for Phase III oncology drug trials, including a minimum 20% improvement in overall survival, with a higher bar for certain diseases.

FDA approved Pfizer’s lung cancer drug for patients positive for the gene translocation – but review documents show that agency reviewers focused on the efficacy seen in the few ALK-negative patients in the pivotal trial, and want Pfizer to follow up on that signal post-marketing. Regulatory expectations for disproving effect in the non-selected population will be an important issue as more personalized medicines reach the agency.

FDA Commissioner Margaret Hamburg, along with AHRQ Director Carolyn Clancy, reflects on why there is a buzz around patient-centered health care and what patient engagement can mean to drug development and health care as a whole.