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