A Welcome FDA Reversal on a Melanoma Drug - WSJ editorial
Some good news to finish the week. Replimune said Friday that the Food and Drug Administration has agreed to reconsider its treatment for metastatic melanoma on an expedited basis. This bodes well for patients with melanoma and other diseases who were casualties of the prior FDA regime’s arbitrary drug rejections.
Marty Makary resigned earlier this month as FDA commissioner after the agency’s rejection of treatments for rare and debilitating diseases sparked anger among patients, doctors and Members of Congress. The FDA moved the goal posts for approvals and demanded double-blind randomized controlled trials that would be impractical or unethical.
Replimune’s RP1 is a case in point. More than half of patients with metastatic melanoma will stop responding to approved immunotherapies, after which most won’t live much more than a year. Yet one-third of patients who received RP1 after progressing on other drugs entered remission, and tumors shrank in nearly all.
FDA staffers who reviewed RP1 supported its approval. Yet Dr. Makary’s deputy Vinay Prasad overruled them and rejected the drug because the trial lacked a control group. This would have been unethical, as oncologists explained to the FDA. Drs. Makary and Prasad responded by claiming critics are in the pocket of Big Pharma.
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