FDA Rejects Replimune's Melanoma Drug for a Second Time

By Kelly Cloonan

The Food and Drug Administration rejected Replimune Group's application for an advanced melanoma drug for a second time.

FDA said Friday the data Replimune provided doesn't show substantial evidence that RP1, also known as vusolimogene oderparepvec, is effective in treating unresectable advanced cutaneous melanoma and therefore doesn't meet the standards required for regulatory approval.

The FDA had initially rejected an application for the therapy in July, and accepted Replimune's resubmission for consideration in October.

The FDA said the additional exploratory analyses of the data that Replimune provided this time didn't change its prior conclusion that the clinical trial data provided fails to demonstrate substantial evidence of effectiveness.

The agency pointed to issues with the trial's inability to isolate the contribution of vusolimogene oderparepvec when administered in combination with nivolumab, as well as concerns over the heterogeneity of the study population.

Shares of Replimune slid 19% to $4.76 on Friday. The stock is down 51% year to date.

Write to Kelly Cloonan at [e-mail]

(END) Dow Jones Newswires

04-10-26 1304ET