STAT is live-blogging a meeting of FDA experts to review Replimune’s experimental melanoma drug, RP1.
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.