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The U.S. Food and Drug Administration has approved Kyprolis to treat patients with multiple myeloma and have received at least two prior therapies.
Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, said Kyprolis provides a treatment option to patients with multiple myeloma whose disease has progressed despite use of available therapies.
"We are encouraged by the continued progress in the development of drugs for multiple myeloma over the past decade, offering improved treatment of this disease," Pazdur said.
Multiple myeloma is a form of blood cancer that arises from plasma cells, which 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.
Kyprolis said the treatment is administered directly into a patient's vein.
Researchers tested Kyprolis on 266 patients with relapsed multiple myeloma who had received at least two prior therapies, including Velcade and Thalomid.
Twenty-three percent of the patients who took Kyprolis experienced complete or partial disappearance of tumor after treatment. Patients were on the treatment for an average of eight months.
The most common side effects of Kyprolis are fatigue, low blood cell count and blood platelet levels, shortness of breath, diarrhea, and fever. Serious side effects seen with Kyprolis included heart failure and shortness of breath.
Patients should be monitored closely and treatment withheld if these serious side effects occur.
Krypolis is marketed by Onyx Pharmaceuticals.
According to Onyx, up to 15,000 Americans will be eligible for the treatment, which will be available for order from doctors by August 1.
The FDA approved Kyprolis under accelerated approval, an application process where a single clinical trial is sufficient to show benefit in order to get a drug to patients sooner. The company must then conduct a follow-up study to confirm the drug actually keeps the disease from getting worse, or helps people live longer.
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The U.S. Food and Drug Administration has approved Kyprolis to treat patients with multiple myeloma and have received at least two prior therapies.
Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, said Kyprolis provides a treatment option to patients with multiple myeloma whose disease has progressed despite use of available therapies.
"We are encouraged by the continued progress in the development of drugs for multiple myeloma over the past decade, offering improved treatment of this disease," Pazdur said.
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Multiple myeloma is a form of blood cancer that arises from plasma cells, which 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.
Kyprolis said the treatment is administered directly into a patient's vein.
Researchers tested Kyprolis on 266 patients with relapsed multiple myeloma who had received at least two prior therapies, including Velcade and Thalomid.
Twenty-three percent of the patients who took Kyprolis experienced complete or partial disappearance of tumor after treatment. Patients were on the treatment for an average of eight months.
The most common side effects of Kyprolis are fatigue, low blood cell count and blood platelet levels, shortness of breath, diarrhea, and fever. Serious side effects seen with Kyprolis included heart failure and shortness of breath.
Patients should be monitored closely and treatment withheld if these serious side effects occur.
Krypolis is marketed by Onyx Pharmaceuticals.
According to Onyx, up to 15,000 Americans will be eligible for the treatment, which will be available for order from doctors by August 1.
The FDA approved Kyprolis under accelerated approval, an application process where a single clinical trial is sufficient to show benefit in order to get a drug to patients sooner. The company must then conduct a follow-up study to confirm the drug actually keeps the disease from getting worse, or helps people live longer.