FDA Approves Bristol-Myers' Yervoy, Opdivo for Treatment of Melanoma
October 01 2015 - 11:32AM
Dow Jones News
By Peter Loftus and Ron Winslow
The U.S. Food and Drug Administration approved the first therapy
combining two cutting-edge cancer drugs that unleash the body's
immune system against tumors. The combination will cost more than
$250,000 per patient for the first year of treatment, Bristol-Myers
Squibb Co. said.
Bristol-Myers said Thursday the FDA approved the use of its
drugs Yervoy and Opdivo for the treatment of advanced melanoma, a
deadly form of skin cancer. Each immunotherapy previously was
approved individually to treat melanoma; they work by different
mechanisms to fight tumors.
A Bristol-funded study showed a combination of the two drugs
significantly shrank tumors in 60% of melanoma patients, versus 11%
of patients receiving Yervoy alone. The combination also increased
the risk of serious adverse events such as the gastrointestinal
disorder colitis.
Yervoy is given as a fixed regimen of four doses over 12 weeks.
The cost for the initial 12-week phase of the combination is about
$141,000, and then $12,500 a month for Opdivo alone, totaling
roughly $256,000 if a patient stays on therapy for a year,
according to a Bristol-Myers spokeswoman. Opdivo is taken until a
patient experiences disease progression or unacceptable toxicity
from the drug. Subsequent full-year costs of therapy would be about
$150,000 for Opdivo alone.
Write to Peter Loftus at peter.loftus@wsj.com and Ron Winslow at
ron.winslow@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
October 01, 2015 11:17 ET (15:17 GMT)
Copyright (c) 2015 Dow Jones & Company, Inc.
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