FDA approves new lung cancer therapy

The U.S. Food and Drug Administration on Friday approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.

Opdivo targets the cellular pathway known as PD-1/PD-L1 -- proteins found on the body’s immune cells and some cancer cells. Through obstructing this pathway, Opdivo can help the body’s immune system fight the cancer cells.

“There is still a lot to learn about the PD-1/PD-L1 pathway and its effects in lung cancer, as well as other tumor types,” Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research, said. “While Opdivo showed an overall survival benefit in certain non-small cell lung cancer patients, it appears that higher expression of PD-L1 in a patient’s tumor predicts those most likely to benefit.”

Lung cancer is the leading cause of cancer death in the United States. There have been an estimated 221,200 new lung cancer diagnoses and 158,040 deaths this year, and the most common type of lung cancer is non-small cell lung cancer.

Opdivo was approved around three months ahead of the prescription drug user fee goal date of Jan. 2, 2016. Bristol-Myers Squibb, based in Princeton, New Jersey, markets Opdivo.

Want to get notified whenever we write about U.S. Food and Drug Administration (FDA) ?
Next time we write about U.S. Food and Drug Administration (FDA), we'll email you a link to the story. You may edit your settings or unsubscribe at any time.
Organizations in this story

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