Replimune to file third FDA application for RP1 cancer therapy after productive talks
Replimune announced it will submit a third marketing application for its experimental cancer therapy RP1, following what the company described as productive discussions with the Food and Drug Administration.
The therapy, tested in combination with Bristol Myers Squibb's Opdivo for skin cancer, has been rejected twice previously. Its initial submission in late 2024 was based on data from a mid-stage trial that enrolled 140 patients.
Replimune says the FDA views the case as urgent and plans to prioritize the review of the new application.
CEO Sushil Patel thanked the agency's leadership for engaging in a collaborative dialogue aimed at finding a path forward for RP1.
This writeup was produced by pharmadog from original reporting by BioPharma Dive.
Original headline: “Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks”
read at BioPharma Dive ↗
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