FDA approves Opdivo for lung cancer treatment

The U.S. Food and Drug Administration (FDA) has approved Bristol-Myers Squibb Company’s Opdivo (nivolumab) injection for the treatment of patients with metastatic, non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

“Improving survival for cancer patients represents the ultimate goal of treatment,” Murdo Gordon, senior vice president and head of worldwide markets at Bristol-Myers Squibb, said. “With today’s FDA approval, it is encouraging to know that Opdivo will be available to significantly more patients with metastatic NSCLC, helping to improve treatment outcomes for patients who have been previously treated. We hope that our efforts to bring innovative immuno-oncology treatments forward for patients will help increase survivorship and positively impact the lung cancer community.”

This approval is the third U.S. approval for Opdivo this year and are based on the results of a Phase 3 trial that showed higher overall survivor benefit for Opdivo versus docetaxel in previously treated metastatic NSCLC.

“Non-small cell lung cancer is a difficult to treat disease with high mortality, and patients with squamous and non-squamous NSCLC often respond differently to treatment,” Roy Herbst, chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven, said. “Opdivo is becoming an important treatment option for more patients with previously treated metastatic NSCLC, and is a welcome addition to our therapy of this disease.” 

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Bristol-Myers Squibb 345 Park Ave NY, NY 10154

U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903