The FDA is warning that the toxic side effects of an experimental cancer drug from Onyx Pharmaceuticals may outweigh its benefits for patients with a type of blood cancer.
In a company study of the drug, patients were found to suffer from a high rate of heart and lung side effects, some of which were fatal. These side effects seem to outweigh the drug’s benefits. The researchers studied 266 patients who had already been treated with two other cancer drugs. Only 22% of patients involved in the study responded positively to the drug; however, the typical patient only survived slightly less than 8 months after beginning treatment. Of the 266 patients, 23% suffered heart problems after the medication.
The FDA staff also said that 7 people taking the drug during a clinical trial died from cardiac-related issues. Another 6% of the 266 patients enrolled in the clinical study stopped taking the drug because of cardiac issues.
The FDA will ask its cancer panel to vote on whether the benefits of carfilzomib outweigh the risks. A decision is expected by July 27.
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