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FDA Approves Kyprolis for Multiple Myeloma

Multiple myeloma is a type of blood cancer that usually arises from plasma cells in bone marrow, the site of blood-cell production. In 2012, an estimated 21,700 people will be diagnosed with multiple myeloma and 10,710 will die from the disease, according to the American Cancer Society. The safety and effectiveness of intravenous Kyprolis was evaluated in 266 patients with relapsed multiple myeloma who had received at least two prior therapies, including Velcade and Thalomid (thalidomide). The overall response rate was 23%, and the median duration of response was 7.8 months. The most common side effects (observed in more than 30% of the study participants) included fatigue, low blood cell count and blood platelet levels, shortness of breath, diarrhea, and fever. Serious side effects included heart failure and shortness of breath. Kyprolis was approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The program is designed to provide patients with earlier access to promising new drugs. The company is required to submit additional clinical information after approval to confirm the drug’s clinical benefit. Kyprolis is marketed by Onyx Pharmaceuticals of South San Francisco, Calif. Visit www.fda.gov for more information.

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