As ABC is reporting, an FDA panel voted 13-1 against approving ridaforolimus, saying the side-effects — seen in about 60 percent of studied patients — outweighed the benefits, for this candidate conceived as maintenence therapy, for a relatively rare form of cancer.
. . . .The panel saw less potential for Merck’s ridaforolimus, which the company acquired through Ariad Pharmaceuticals Inc. The group voted 13-1 against the drug, saying its significant side effects — which affected 60 percent of patients — outweighed its benefits.
Merck & Co. Inc. of Whitehouse Station, N.J., submitted the drug as a maintenance therapy, meaning it would be used to help repress sarcoma of the bone and tissue in patients whose cancer is already in remission. Since such patients are healthier than patients with active disease, panelists said they wanted to see a more dramatic benefit to justify putting patients on a drug with major side effects. The FDA has only approved a handful of cancer drugs for maintenance use.
Company trials showed no survival benefit and a meager seven-week delay in disease progression compared with patients not taking the drug. . . .
So it goes.