Rejecting a promising melanoma immunotherapy by the biotech firm Replimune - WSJ Editorial
(Original title: “Dr. Makary and Mr. Hyde at the FDA,” but the one here gives the message)
(snip)
The FDA on Friday for the second time rejected a promising melanoma immunotherapy by the biotech firm Replimune. Some 8,500 Americans die every year of melanoma, many of whom could be saved by Replimune’s RP1. But Dr. Prasad and Commissioner Marty Makary have decided that for whatever reason they aren’t worth saving.
RP1 is an oncolytic virus therapy that turbo-charges the immune response in people resistant to other immunotherapies. A modified herpes virus is injected into tumors, which causes cancer cells to burst and release flares that activate and train the immune system to attack cancer cells throughout the body.
Patients with metastatic melanoma who stop responding to other immunotherapies typically die in less than a year. In Replimune’s trial, tumors shrank in nearly all patients and vanished in one of six. About a third went into remission. FDA staff were so impressed by the results that the agency designated RP1 a “breakthrough therapy” in November 2024 to expedite its review.
As we’ve reported, Dr. Prasad last summer overruled career staff to reject RP1. The agency’s main criticism was that its trial lacked a control arm, though this would be unethical in late-stage patients who failed to improve on other therapies. Oncologists around the world lambasted the FDA.
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Next, the FDA quibbles that patients who had every tumor injected had higher remission rates than those who had only some. It says this raises questions about RP1’s efficacy. Huh? This shows the drug works. The FDA also complains some patient tumors were injected more than once, which may have augmented the therapeutic effects. So what? The letter also bizarrely claims that tumor biopsies—which are done in most cancer trials—could have been the reason that tumors shrank and patients entered remission. If only biopsies had such miraculous effects. The FDA implicitly concedes that the RP1 results are impressive by contriving ridiculous reasons to argue they could be exaggerated.
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https://www.wsj.com/opinion/replimune-melanoma-rp1-fda-vinay-prasad-marty-makary-a45fa5bf?st=iGYKGh&reflink=desktopwebshare_permalink
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