A group of outside experts convened by the Food and Drug Administration on Thursday voted in favor of Replimune’s experimental treatment for advanced melanoma.
In a 10-3 vote, the advisers determined that the biotech company has collected sufficient data to allow the FDA to review RP1, an engineered viral immunotherapy for melanoma. The agency tends to follow the recommendations of its expert panels but is not bound by them.
What comes next could 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.
