Replimune skin cancer drug that became FDA flashpoint is rejected again

The Meals and Drug Administration on Friday rejected — once more — an experimental remedy for superior pores and skin most cancers developed by Replimune Group. 

Replimune’s remedy, an engineered virus designed to rev up the immune system in opposition to melanoma, has been a flashpoint in a simmering debate over shifting requirements on the company.

The drug was initially rejected in July, simply two months after Vinay Prasad was appointed the FDA’s head of biologics. As an instructional oncologist, Prasad criticized regulators for approving medicine with restricted knowledge, and the Replimune resolution was seen as a attainable signal of the stricter stance he may take on the company.