FDA Approves Amgen's Kyprolis As a Second-Line Multiple Myeloma Treatment

By Tess Stynes 

Amgen Inc. said the U.S. Food and Drug Administration granted accelerated approval for its Kyprolis combination therapy as a second-line treatment for patients with relapsed cases of multiple myeloma.

The accelerated approval allows earlier use of Kyprolis for multiple myeloma--an incurable blood cancer that often becomes resistant to treatment.

Sean Harper, head of research and development at Amgen, said in an interview that the U.S. approval "will allow a much broader population to have access to the drug."

Kyprolis, which Amgen gained with its $10.4 billion acquisition of Onyx Pharmaceuticals Inc. in 2013, initially received FDA approval in 2012 as a third-line treatment.

The accelerated approval is based on a Phase 3 study that added Kyprolis to Revlimid and dexamethasone, the previous standard of care. In the study, the three-drug combination showed a 50% improvement in progression-free survival to 26.3 months, compared with 17.6 months with just Revlimid and dexamethasone alone.

Mr. Harper added that in the study the three-drug combination's toxicity didn't increase with the addition of Kyprolis, and that the trial also provided the first clear evidence that Kyprolis doesn't cause peripheral neuropathy.

Kyprolis sales totaled $332 million during 2014, the first full year of commercialization since Amgen acquired Onyx. Domestic sales were $306 million, with the remainder abroad.

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