The U.S. Food and Drug Administration has approved Opdivo (nivolumab) for the treatment of patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-based chemotherapy.

“The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available in late December 2014,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

“This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials.”

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Opdivo is approved as an intravenous infusion at a dose of 3mg/kg administered over 60 minutes every 2 weeks. Opdivo inhibits the PD-1 cellular pathway, thereby blocking the body’s immune system from attacking cancerous cells.

Approval is based on a randomized, open-label study that included 272 patients with metastatic squamous NSCLC who had experienced disease progression during or after one prior platinum double-based chemotherapy regimen.

Patients received either Opdivo 3mg/kg IV every 2 weeks or docetaxel 75mg/m2 IV every 3 weeks. Results showed a median overall survival of 9.2 months (95% CI: 7.3 – 13.3) in the Opdivo group compared with 6.0 months (95% CI: 5.1 – 7.3) in the docetaxel group (HR = 0.59; 95% CI: 0.44 – 0.79; P = 0.79).

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The most common adverse events associated with treatment with Opdivo are fatigue, dyspnea, musculoskeletal pain, decreased appetite, cough, nausea, and constipation.

The most common serious adverse events are severe immune-mediate side effect involving various healthy organs, such as the colon, kidneys, liver, lung, and hormone-producing glands.

Opdivo was initially approved in 2014 for the treatment of patients with unresectable or metastatic melanoma who experienced disease progression following ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor.