Oncologists vs. the FDA and RFK Jr.

Source: wsj.com

TL;DR

The story at a glance

WSJ editorial board responds to RFK Jr.'s defense of FDA Commissioner Marty Makary and biologics chief Vinay Prasad over the rejection of Replimune's RP1, an immunotherapy for metastatic melanoma. RFK Jr. claimed at a House hearing last Thursday that all FDA career panels found the drug ineffective. The board argues this misstates facts, as the initial review panel recommended approval before Prasad's override, amid oncologists' widespread shock at the decision.

Key points

Details and context

RP1 is an oncolytic immunotherapy from Replimune designed for patients with metastatic melanoma unresponsive to standard treatments like anti-PD-1 drugs. The FDA has rejected it at least once before, citing issues like lack of a control arm in trials, which critics say is unethical for late-stage patients with no other options.[[3]](https://www.wsj.com/opinion/replimune-melanoma-rp1-fda-vinay-prasad-marty-makary-a45fa5bf)

This editorial fits WSJ's series criticizing FDA under Makary and Prasad for slowing approvals of promising therapies, especially after breakthrough designations. Oncologists globally have protested the RP1 decision, viewing it as overly strict.[[3]](https://www.wsj.com/opinion/replimune-melanoma-rp1-fda-vinay-prasad-marty-makary-a45fa5bf)

RFK Jr.'s hearing comments came amid backlash against FDA rejections, including a second denial of RP1 around April 10, 2026.[[4]](https://www.aimatmelanoma.org/fda-does-not-approve-rp1-in-combination-with-nivolumab-for-advanced-melanoma-what-this-means-for-patients)

Key quotes

“Every panel within FDA, all the career panels, the career scientists who looked at that drug said it was not effective.” — Robert F. Kennedy Jr., at House hearing.[[1]](https://www.wsj.com/opinion/fda-rp1-replimune-melanoma-drug-rfk-jr-vinay-prasad-marty-makary-b8d666b2?st=MWyZy6)

Why it matters

FDA drug approvals balance speed for patients against evidence standards, and disputes like this highlight tensions in oncology where single-arm trials are common for hard-to-treat cancers. For melanoma patients and investors in Replimune, repeated rejections delay access to a therapy oncologists see as promising and limit options after standard care fails. Watch for Replimune's next steps with FDA, Prasad's impending departure end-April, and any resubmission outcomes, though randomized data demands could prolong uncertainty.

What changed

Omit - no before/after in article.

FAQ

Q: What did RFK Jr. say about FDA panels and RP1?

A: At a House hearing last Thursday, RFK Jr. claimed every FDA career panel and scientists found Replimune's RP1 not effective. WSJ states this is untrue, as the initial panel recommended approval.

Q: Who overruled the FDA panel on RP1?

A: FDA biologics chief Vinay Prasad overruled the initial panel that recommended approving Replimune's RP1 for metastatic melanoma.

Q: Why are oncologists upset about RP1 rejection?

A: Doctors treating melanoma are shocked, viewing RP1 as life-saving for patients with metastatic disease who failed other therapies.

Q: What is the context of WSJ's criticism?

A: WSJ has criticized FDA's rejection of RP1; RFK Jr. called those criticisms bewildering during his House testimony defending the agency.