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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| Bristol Myers Squibb Co | NYSE:BMY | NYSE | Common Stock |
| Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|
| 0.18 | 0.40% | 44.88 | 45.37 | 44.34 | 44.73 | 21,281,928 | 01:00:00 |
From Apr 2019 to Apr 2024
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.
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
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