UPDATE 2-Replimune gets third chance at US approval for skin cancer drug
Replimune REPL | 0.00 | |
Bristol-Myers Squibb Company BMY | 0.00 |
Updates shares, adds background throughout
May 29 (Reuters) - Replimune REPL.O said on Friday it has reached an agreement with the U.S. Food and Drug Administration to resubmit the marketing application for its experimental skin cancer drug after the regulator twice declined to approve the therapy.
Shares of the company jumped nearly 68% after Replimune said it would resubmit its application for vusolimogene oderparepvec in the coming days.
The regulator declined to approve the drug, also known as RP1, in April, citing reliance on a single-arm study without a control group.
In its so-called complete response letter, the agency said the company must provide data from a well-controlled trial demonstrating adequate evidence of the drug's effectiveness.
Replimune said on Friday that the FDA has indicated it will treat the resubmission as an urgent matter upon receipt and prioritize its review.
The company is seeking approval for RP1 in combination with Bristol Myers Squibb's BMY.N immunotherapy Opdivo for the treatment of advanced melanoma, a highly aggressive form of skin cancer.
About 112,000 new melanoma cases and 8,510 deaths are estimated in the U.S. this year, according to the company.
