AstraZeneca’s Imfinzi scores lung cancer wins with FDA’s NSCLC approval, SCLC priority review
AstraZeneca’s Imfinzi scores lung cancer wins with FDA’s NSCLC approval, SCLC priority review
AstraZeneca touted two lung cancer victories on Thursday with its blockbuster PD-1 inhibitor Imfinzi (durvalumab) securing the FDA’s nod for a perioperative label expansion in non-small cell lung cancer, as well as the regulator’s Priority Review and Breakthrough Therapy designations for small cell lung cancer.
The perioperative approval came as a bit of a surprise. Last month, the FDA’s Oncologic Drugs Advisory Committee expressed strong skepticism about using Imfinzi both before and after surgery and flagged the risk of overtreatment. Due to these concerns, the advisory committee unanimously supported the need to change trial designs for drugs being proposed as perioperative treatments.
David Mitchell, president of the Patients for Affordable Drugs and who acted as consumer representative in the adcomm meeting, insisted that doctors need to know “which phase of treatment is contributing what,” adding that it is “not acceptable” to expose patients to a year of adjuvant treatment and its toxicities “not knowing if it’s doing any good whatsoever.”
The FDA’s internal reviewers expressed similar concerns. In a joint briefing document released prior to the adcomm meeting, the regulator’s staffers maintained that if Imfinzi’s therapeutic benefit mostly came from the neoadjuvant phase, then using it as an adjuvant treatment “would expose patients to overtreatment and its attendant safety risks and additional treatment burden without added clinical benefit.”
Despite these uncertainties and safety risks, the FDA’s external advisors could not recommend asking AstraZeneca to run another trial.
Reuters
