The US Food & Drug Administration's Oncologic Drug Advisory Committee (ODAC) almost unanimously (vote: 13-1) rejected the Merck & Co. submission to have the drug ridaforolimus be approved for maintenance therapy in the treatment of soft-tissue sarcomas whose disease is already in remission.
ODAC said the drug's side effects--lung irritation, kidney failure and high blood pressure, among others--outweighed the limited benefit offered.
The Committee said that the target patient population is healthier than people with active disease and it therefore demanded a much greater benefit from the drug in order to justify risking the health of these patients with these potential side effects.
Nobody should be surprised: Clinical trials of the drug showed no survival benefit and just seven weeks' delay in disease progression compared with patients not taking the drug.
The FDA is not obligated to accept the committee's recommendations, but they typically do.
Source: Therapeutics Daily
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