FDA Decision on Bristol-Myers Squibb Drug Opdivo Is Pushed Back

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.

By Maria Armental

The Wall Street Journal

Updated Aug. 12, 2015 7:05 p.m. ET

—Ron Winslow contributed to this article.

Write to Maria Armental at [email protected]

Corrections & Amplifications:
The name of Bristol-Myers Squibb Co.’s cancer drug is Opdivo. An earlier version of this article incorrectly stated the name of the drug. (Aug. 12, 2015)

Source: Wall Street Journal Health