What happened at FDA? Replimune approval raises questions

Last week, FDA granted accelerated approval to Replimune Group Inc. for it’s biologic, RP1 (vusolimogene oderparepvec), following the FDA Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.

The approval and the CTGTAC decision follows a years-long imbroglio with two previous applications for RP1 bouncing back to Replimune. 

After the first Complete Response Letter from FDA, in July 2025, melanoma experts and patient advocates pressed the agency to reconsider and conduct another review, with FDA receiving several letters from experts from Roswell Park Cancer Institute, Banner MD Anderson, and Moffitt Cancer Center.

Ultimately, Congress, the White House, and HHS were drawn into the dance. According to a report from the Wall Street Journal, the White House pushed FDA to get Replimune its third review after the company “met with the White House in early May, arguing the rejections didn’t match up with the Trump administration’s desire to help terminally ill patients.”

In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher with The Cancer Letter, and Jacquelyn Cobb, associate editor, discuss the implications of this news on the future of the agency and drug development. 

“Now, there is no way in the heck that anyone can predict what FDA is going to do and why and how,” Paul said. “In the past, you could sort of figure it out. You know, ‘Oh, you have no chance here.’ In this case, I don't know. I mean, I'm in the fog.

“Prepare for more of these because what we've seen is FDA not acting the way FDA ever has. FDA just being something else. I don't know what that means. I don't think anybody else knows what that means…

“I've never been more puzzled writing a story about FDA, and I think this is just the beginning.”

This episode is sponsored by the University of Kentucky Markey Cancer Center. Learn more at ukhealthcare.com/markey.

Stories mentioned in this podcast include:

• New directors Herbst and Gius chart a future built on AI, collaboration, and rural access

• FDA grants Replimune's RP1 an accelerated approval on third submission after 10:3 vote from advisory committee

• Consumers are increasingly accessing U.S. News rankings of cancer hospitals via AI chatbots 2026 report shows no change in the top-five lineup

• Marketing hope before surgery: Does the new Keytruda commercial tell patients the whole story? 

• Senate leaders introduce revised, bipartisan stopgap bill that would ban OMB from finalizing rule that would politicize science 

• Federal judge declines to block Medicaid work requirements 

• HRSA redrafts 340B rebate pilot program after courts block the original version 

A transcript of this podcast is available: https://cancerletter.com/podcastc/20260812-replimune/