FDA advisers back carfilzomib for multiple myeloma
*As noted in the article, the Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Kyprolis NDA for accelerated approval is July 27, 2012. The ODAC provides FDA with independent expert advice and recommendations and the final decision regarding approval is made by FDA.
Last Updated: 2012-06-20 18:10:29 -0400 (Reuters Health)
SILVER SPRING, Md. (Reuters) - A panel of outside advisers to the U.S. Food and Drug Administration voted unanimously Wednesday to recommend approval of carfilzomib (Kyprolis, Onyx Pharmaceuticals Inc) for patients with multiple myeloma who have not had success with at least two other older drugs.
The older treatments must include bortezomib (Velcade, Takeda Pharmaceutical Co Ltd) and Celgene Corp's Revlimid (lenalidomide) or Thalomid (thalidomide).
Onyx said about a fifth of all myeloma patients have cancer that no longer responds to standard drugs, leaving room for another option.
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.
Panel members said the drug gave people another option to try to beat back the disease.
"I do think this drug is beneficial to this patient population given the limited therapeutic options available," said Dr. Michael Menefee, assistant professor in hematology and oncology at the Mayo Clinic.
The FDA usually follows panel recommendations, although it is not required to, and will make a final decision by July 27.
About 23% of people taking carfilzomib had some response to it during clinical trials, and the response lasted for just under eight months, the company said.
The company tested its drug in 266 patients in a single-arm study. The company is also testing the drug in a larger study, but results will not be available for at least a year.
The company is also testing the drug in newly-diagnosed multiple myeloma patients.
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