STAT+: Tracking the FDA expert review of Replimune’s melanoma treatment

Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.Welcome to STAT’s live blog of a meeting, convened by the Food and Drug Administration, to review Replimune’s experimental treatment for melanoma. The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee is meeting Thursday to evaluate whether the biotech company has collected sufficient data to support the accelerated approval of RP1, an engineered viral immunotherapy for melanoma. The agency tends to follow the recommendations of its expert panels but is not bound by them. The vote will be seen by some as a signal of how the FDA, under new leadership, weighs potential benefits and risks when it comes to investigational drugs. RP1 was rejected in April, under former FDA leaders Marty Makary and Vinay Prasad. Investors have interpreted the FDA’s decision to hold an advisory committee meeting about the drug as a sign of new lenience. But STAT has reported that earlier resistance to RP1 was based on the views of the FDA’s career staff, not leadership. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. Already have an account? Log in View All Plans To read the rest of this story subscribe to STAT+. Subscribe