The U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) on Oct. 9.
The treatment is indicated for patients whose disease progressed during or after platinum-based chemotherapy.
Opdivo may help the body’s immune system fight the cancer cells by blocking the cellular pathway PD-1/PD-L1, which are proteins found on immune cells and some cancer cells.
Earlier this year, the FDA approved Opdivo to treat patients with advanced squamous NSCLC whose disease progressed during or after platinum-based chemotherapy.
“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,” FDA Center for Drug Evaluation and Research's Office of Hematology and Oncology Products Director Richard Pazdur 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.”
Optivo was the subject of a random study of 582 patients. Those treated with Opdivo lived an average of 12.2 months compared to 9.4 months in those treated with docetaxel.
Optivo's approval came three months ahead of schedule.
