Opdivo approval expanded by FDA to include lung cancer treatment
US Food and Drug Administration
(HealthDay News) -- U.S. Food and Drug Administration approval of Opdivo (nivolumab) has been expanded to include advanced non-small-cell lung cancer (NSCLC), the agency said Wednesday in a news release. The drug was approved previously to treat advanced melanoma among people who don't respond to other medicines.
Opdivo inhibits the cellular pathway known as PD-1 protein on cells that prevents the immune system from attacking cancer cells, the agency said. The drug is sanctioned for people who have been treated with platinum-based chemotherapy.
Opdivo was clinically compared to another anti-cancer drug, docetaxel, in a study involving more than 270 people with NSCLC. People who received Opdivo lived an average of 3.2 months longer than people given docetaxel, the FDA said.
The most common side effects of Opdivo are fatigue, shortness of breath, musculoskeletal pain, loss of appetite, cough, nausea, and constipation. More severe adverse effects included immune reactions involving healthy organs, including the lungs, colon, liver, kidneys, and hormone-producing glands.
The drug is marketed by Bristol-Myers Squibb, based in Princeton, N.J.