Kyprolis Approved for Multiple Myeloma

HealthDay – 1 hr 23 mins ago FRIDAY, July 20 (HealthDay News) -- Kyprolis (carfilzomib) has been approved by the U.S. Food and Drug Administration to treat certain people with multiple myeloma who have already been given at least two prior therapies.

Multiple myeloma is a form of cancer that arises from blood plasma, usually starting in the bone marrow, the agency said in a news release. More than 21,000 people in the United States are expected to be diagnosed with the disease this year, and about 10,700 will die from it, the American Cancer Society estimates.

Kyprolis has been approved for people treated previously with the anti-cancer drug bortezomib, and an immunomodulatory therapy such as thalidomide.

The most common side effects observed during clinical testing of Kyprolis included fatigue, low blood cell counts, low platelet counts, diarrhea and fever. More serious but less common adverse reactions included heart failure and shortness of breath, the FDA said.

Kyprolis is marketed by San Francisco-based Onyx Pharmaceuticals.

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U.S. FDA OKs Onyx's Kyprolis for multiple myeloma

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FDA approves Onyx blood cancer drug Kyprolis

The Food and Drug Administration said Friday it approved a new blood cancer drug from Onyx Pharmaceuticals Inc. for patients with advanced disease who have not responded to at least two other drugs.

The injectable drug Kyprolis treats multiple myeloma, a form of cancer that causes tumors to grow in the bone marrow, preventing the production of normal blood cells. Patients with the disease have low red blood cell counts and are more likely to experience infections and excessive bleeding.

The FDA approved the drug for patients who have already tried at least two other drugs, including Velcade and various drugs that boost the immune system.

Shares of South San Francisco, Calif.-based Onyx Pharmaceuticals rose $6.34, or 9.3 percent, to $74.74.

The company studied the drug in 266 patients with advanced multiple myeloma who had already been treated with Velcade and thalidomide. About 23 percent of patients experienced a full or partial disappearance of their tumors, with the typical effect lasting about 7.8 months.

Thirty percent of patients experienced side effects from the drug, including fatigue, fever, shortness of breath and diarrhea.

About 21,700 people will be diagnosed with multiple myeloma this year and 10,710 will die from the disease, according to the American Cancer Society.

The drug was approved under the FDA's accelerated approval program, which allows the agency to clear drugs based on promising preliminary data. Drug companies have to submit follow-up studies showing that the drug performed as expected.

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