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.
Write to Tess Stynes at tess.stynes@wsj.com
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