Opdivo Approved for Expanded Use in Treatment of Lung Cancer
For people suffering from certain types of lung cancer, there could be a new treatment option on the horizon.
Last week, the Food and Drug Administration approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy.
NSCLC is the most common type of lung cancer. It is divided into two main types, named for the kinds of cells found in the cancer – squamous cell and non-squamous cell (which includes adenocarcinoma). Earlier this year, the FDA approved Opdivo to treat patients with advanced squamous NSCLC, but this most recent announcement will allow the drug to be administered to patients suffering from non-squamous NSCLC.
Opdivo works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body's immune cells and some cancer cells). By blocking this pathway, Opdivo may 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's Center for Drug Evaluation and Research, said in a written statement. "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."
The safety and effectiveness of Opdivo for this use was demonstrated in an international, open-label, randomized study of 582 participants. Those treated with Opdivo lived an average of 12.2 months compared to 9.4 months in those treated with the alternative option, docetaxel. Additionally, 19 percent of those treated with Opdivo experienced a complete or partial shrinkage of their tumors, an effect that lasted an average of 17 months, compared to 12 percent among those taking docetaxel, which lasted an average of six months.
The most common side effects of Opdivo are fatigue, musculoskeletal pain, decreased appetite, cough and constipation.
Opdivo is marketed by Bristol-Myers Squibb.