FDA staff focus on side effects of carfilzomib
Last Updated: 2012-06-18 14:20:08 -0400 (Reuters Health)
WASHINGTON (Reuters) - U.S. drug reviewers said the serious heart, lung and liver side effects of Onyx Pharmaceuticals Inc's selective proteasome inhibitor carfilzomib may outweigh the drug's benefits for patients with multiple myeloma.
The Food and Drug Administration staff said about 22% of people taking the drug during a key clinical trial responded to the treatment, and many had severe side effects, meaning carfilzomib may not be better than older treatments for multiple myeloma.
"FDA is very concerned with the severe toxicities, including deaths that are associated with the use of this agent," the reviewers said in documents posted online on Monday, adding that it was not clear whether the drug caused the side effects.
"Considering these factors, the risks of carfilzomib may not outweigh its benefits," they said.
The FDA staff review comes ahead of an advisory panel, which will vote on whether to recommend the drug on Wednesday. The FDA will make a final decision later, taking into account the panel's recommendations.
In 2012, about 21,700 new cases of multiple myeloma will be diagnosed in the United States, and about 10,710 people will die from the disease, according to the American Cancer Society.
Onyx wants to get approval of its drug, to be sold as Kyprolis, for people who have not had success with at least two other treatments for multiple myeloma, or cannot tolerate the older drugs.
The older treatments must include Takeda Pharmaceutical Co Ltd's Velcade (bortezomib) and Celgene Corp's Revlimid (lenalidomide) or Thalomid (thalidomide).
But the FDA staff said Onyx did not prove that people taking Kyprolis in clinical trials had failed with all of the seven drugs approved for multiple myeloma.
They also said Revlimid and Thalomid, among others, did not have the same serious side effects as Kyprolis.
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