WASHINGTON (AP) — 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.
