USFDA Rejects Replimune's RP1 for Advanced Melanoma, Flags Insufficient Data
Bengaluru: The U.S. Food and Drug Administration on Friday declined to approve Replimune's drug for advanced skin cancer citing insufficient data from studies, a letter from the regulator showed.
This marks the second consecutive setback for Replimune, which was seeking approval for its drug RP1 to treat the most advanced form of the condition, dealing a blow to the drug developer's efforts to introduce its first marketed product.
The U.S. regulator had also declined to approve the drug last year, citing issues in clinical trials and inadequate evidence of effectiveness. Replimune's shares were halted in morning trading.
The FDA's latest so-called complete response letter said that data from two studies were not strong enough to support approval of the treatment in combination with Bristol Myers Squibb's Opdivo for adults with advanced melanoma.
Advanced melanoma is a serious form of skin cancer that rapidly spreads to other parts of the body, making it harder to treat. The drug's previous rejection was during the tenure of the FDA's then biologics unit chief Vinay Prasad, who departed the agency for the second time in February following internal tussles. The recent high-profile dispute over the review of Moderna's influenza shot also unfolded when Prasad was at the agency.
Replimune did not immediately respond to a Reuters request for comment.
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