By Maria Armental
The Food and Drug Administration pushed back the decision date
on an expanded use of Bristol-Myers Squibb Co.'s cancer drug Opdivo
to Nov. 27, Bristol-Myers said Wednesday.
Bristol-Myers, which initially said a decision was expected by
Aug. 27, said it had submitted additional clinical-trial data,
which amounts to a "Major amendment" that requires additional time
to review.
Opdivo, also known as nivolumab, was first approved for sale in
December to treat patients with advanced melanoma, a skin cancer.
In March, the FDA extended the use to treat advanced lung cancer.
The current indication under review would be for patients with
previously untreated advanced melanoma.
Opdivo and its rivals work by interfering with a molecular brake
known as PD-1 that prevents the body's immune system from attacking
tumors.
Opdivo added about $122 million to sales in the second-quarter,
Bristol-Myers said.
Ron Winslow contributed to this article.
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