RP1
Coverage of RP1 in the Nexus archive.
- STAT+: Pharmalittle: We’re reading about a Novo setback, support for Replimune’s melanoma drug, and more
An FDA advisory panel recommended Replimune's experimental melanoma drug RP1 after a 10-3 vote, but the weight loss drug market shows signs of slowing as employers and insurers reduce coverage. The FDA's new leadership is being observed for its approach to evaluating investigational drugs.
- FDA advisory panel backed Replimune's twice-rejected melanoma treatment in 10-3 vote
The FDA advisory panel supported Replimune's melanoma treatment RP1 in a 10-3 vote, increasing its chances of approval before the Aug. 2 deadline. RP1 is an engineered viral immunotherapy previously rejected by the FDA.
- STAT+: FDA staff reiterate concerns about Replimune skin cancer treatment
FDA staff have reiterated concerns about insufficient data to support approval of Replimune’s investigational skin cancer treatment RP1. The agency criticized a single-arm trial combining RP1 with Opdivo, arguing it fails to establish the drug’s efficacy or systemic benefits, while Replimune claims ethical and feasibility challenges prevent a placebo-controlled study.
- FDA blocked melanoma drug as confusion reigned under Makary
The FDA blocked a melanoma drug due to confusion under Makary's leadership. A clinical trial showed that a third of patients had tumors shrink while taking RP1, a genetically engineered treatment. The trial results were promising despite the FDA blockage.