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.
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