FDA approves Kyprolis (Onyx Pharma) for Multiple Myeloma

The FDA has approved Kyprolis (carfilzomib) from Onyx Pharma to treat patients with Multiple Myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy. A form of blood cancer that arises from plasma cells, Multiple Myeloma usually grows in bone marrow, the soft, spongy tissue found inside most bones. The bone marrow is where normal blood cells are produced. 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 Kyprolis, which is administered directly into a patient’s vein (intravenously), was evaluated in a study of 266 patients with relapsed Multiple Myeloma who had received at least two prior therapies, including Velcade and Thalomid (thalidomide). The study was designed to measure the percentage of patients who experienced complete or partial disappearance of tumor after treatment (overall response rate). The overall response rate was 23 percent. The median duration of response was 7.8 months.