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Amgen cancer drug Kyprolis to get expedited review from FDA

By   /   Friday, September 18th, 2015  /   Comments Off on Amgen cancer drug Kyprolis to get expedited review from FDA

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An experimental multiple myeloma treatment using Amgen’s Kyprolis will get an expedited review from the U.S. Food and Drug Administration.

The FDA said it will use an expedited review process to review a multiple-myeloma treatment using Kyprolis and the genric drug dexamethasone. On July 23, Amgen submitted additional data to the FDA which compared this treatment to a rival drug made by Takeda Pharmaceuticals.

Multiple-myeloma is a form of blood cancer that forms in plasma cells and typically grows in bone marrow. According to the American Cancer Society, 27,000 Americans will be diagnosed with multiple-myeloma in 2015, and 11,000 will die from the disease. In March, Amgen announced that the study showed patients who took Kyprolis had a progression-free survival rate of about 19 progression-free months, compared to about nine months for Velcade.

This therapy is for patients who have received at least one prior treatment for multiple-myeloma.

“The acceptance of this submission is an important next step toward providing more options for patients with relapsed multiple-myeloma and we look forward to working with the FDA over the coming months,” said Sean Harper, Amgen executive vice president of research and development, in a news release.

Like many recent Amgen drugs, Kyprolis has been criticized for its high cost. Kyprolis typically costs $10,000 per 28-day cycle.

The drug was approved by itself for third-line treatments in 2012, and approved for second-line treatments on July 24. A new study is currently under way testing Kyprolis as a drug used for first line treatments for multiple-myeloma.

This story was updated to reflect that the FDA will use an expidited review process to review a treatment using Kyprolis and dexamethasone, not Kyprolis and Revlimid.

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