A federal regulatory panel has rejected ridaforolimus as a treatment for sarcoma, a rare form of cancer.
An FDA panel of cancer experts voted 13-1 against the drug, which Merck & Co. Inc. acquired from Ariad Pharmaceuticals, saying its side effects outweighed its benefits. Side effects included lung irritation, kidney failure and high blood pressure.
Merck, 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 Food and Drug Administration 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. Sarcoma is a rare class of tumors that form in the fat, muscles and bone in the limbs and abdomen.
The FDA is scheduled to decide on the drug by June. It is not required to follow the advice of its panelists, though it usually does.
If the drug is approved, Merck will pay Ariad $25 million and the two companies will collaborate on marketing.
Date: March 21, 2012
Source: Associated Press
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