FDA expands Opdivo use for some NSCLC patients

SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Bristol-Myers Squibb’s Opdivo (nivolumab) as a treatment for advanced lung cancer. 

The drug can now be used on patients whose non-small cell lung cancer metastasized while undergoing platinum-based chemotherapy or after. The drug had been approved earlier this year for a different type of non-small cell lung cancer.

Opdivo woks by targeting proteins (PD-1/PD-L1) that are found in some cancer cells, potentially boosting the immune system’s ability to fight the cancer.

“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,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “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.” 

Along with the new use for the drug, the FDA also approved a test to detect PD-L1 levels in order to help physicians find patients who would benefit the most from Opdivo.