FDA Staff Unconvinced Drug for Melanoma Shows Benefit

FDA reviewers criticize Replimune drug; ProMIS climbs on Alzheimer’s data

Replimune shares plummeted 40% on concerns FDA scientists are still skeptical of its melanoma drug. Elsewhere, investors had a muted reaction to a first-of-its-kind study result.

FDA Staff Unconvinced Drug for Melanoma Shows Benefit

(MedPage Today) -- Another attempt to win accelerated approval for RP1 (vusolimogene oderparepvec) -- a melanoma drug candidate that's already been rejected twice by the FDA -- could face tough going at a meeting of FDA's outside experts this...

FDA Review Raises Questions About Replimune’s Melanoma Therapy Ahead of Advisory Committee Vote

As reported on Reuters, Replimune’s experimental cancer treatment RP1 is facing increased regulatory scrutiny after U.S. Food and Drug Administration (FDA) reviewers expressed concerns about whether current clinical data adequately demonstrate the drug’s effectiveness in patients with advanced melanoma. The agency’s assessment, released in briefing materials ahead of an upcoming advisory committee meeting, concluded that […]