FDA Advisory Committee Weighs In: Melanoma Drug Gains Support, Duchenne Treatment Falters, Non-Opioid Pain Drug Shines

FDA advisors handed Replimune a surprise lifeline on Wednesday, voting 10-3 to support its melanoma drug RP1 despite agency staff skepticism. The oncolytic immunotherapy, combined with nivolumab (Opdivo), showed a 33.6% response rate in advanced melanoma patients who had already failed anti-PD-1 therapy—a population with notoriously low odds. Complete responses hit 16.4%, with a median duration of 24.8 months. The vote bucks two previous FDA rejections and...