FDA Advisory Panel Recommends Against Approval of Genta Antisense Drug
Genta said this week that the US Food and Drug Administration’s Oncologic Drugs Advisory Committee has voted that the company’s phase III trial for its antisense cancer drug Genasense does not indicate the drug’s efficacy is substantial enough to outweigh its risks.
The FDA is not bound to follow the advice of its advisory committees, although it usually does. The news devastated Genta’s stock, which tumbled more than 40 percent.