Tanja Obradovic: FDA’s Review of RP1 for Relapsed/Refractory Melanoma and the Challenges of Launching New Cancer Therapies
Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn:
“Among several incoming PDUFA dates this month on July 22nd FDA will be reviewing RP1 (vusolimogene oderparepvec) by Replimune in relapsed/refractory melanoma post anti-PD-1 in combination with Nivolumab.
RP1 is an HSV-1–based oncolytic immunotherapy expressing human GM-CSF and a fusogenic protein (GALV-GP-R−) and PDUFA is based on results of the phase 1/2 IGNYTE trial (NCT03767348). Although in different trials efficacy of RP1 looks similar to Iovance Biotherapeutics, Inc. approved tumor infiltrating lymphocyte (TIL) therapy Amtagvi in this patient population.
In the post PDUFA time even under positive outcome there will be uphill process of launch and a need for the proper medical strategy for sufficient impact at the bedside. Example of the challenge is Amtagvi as Iovance Biotherapeutics, Inc., recently commented that TIL product sold well below forecasts at just $44m in the first quarter, and 2025 full-year company revenue forecast went from $450-475m to $240-300m.”
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