Opdivo (Nivolumab) Approved for Lung Cancer

The United States Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for the treatment of advanced lung cancer.

Specifically, the indication for which Opdivo was approved is treatment of advanced, squamous non-small cell lung cancer (NSCLC) that has continued to grow following platinum-based chemotherapy.

Opdivo is also approved for the treatment of advanced melanoma that has stopped responding to standard therapies.

Opdivo blocks a pathway referred to as PD-1. PD-1 stops the body’s immune system from attacking cancerous cells. Therefore, through blocking PD-1, Opdivo allows the body’s immune system to fight the cancer cells.

The clinical trial that prompted the approval of Opdivo in NSCLC included 272 patients: one group was treated with Opdivo and the second group was treated with the chemotherapy agent docetaxel.

Overall, patients treated with Opdivo survived 3.2 months longer than those treated with docetaxel.

A second trial that was conducted to evaluate the safety of Opdivo included 117 patients who were all treated with Opdivo after they stopped responding to standard therapy.

15% of all patients experienced shrinkage of their cancer, or complete regression of their cancer.
Of these responders, nearly 60% had responses that lasted at least 6 months.
Reference: United States Food and Drug Administration. FDA expands approved use of Opdivo to treat lung cancer. Available at:

Accessed March 5, 2015