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The Food and Drug Administration has expanded the approved use of Opdivo (nivolumab) for the treatment of patients with metastatic squamous non-small-cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy. Opdivo, made by Bristol-Myers Squibb, works by inhibiting the PD-1 pathway, which blocks the body's immune system from attacking cancer cells.

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The drug had previously received accelerated approval to treat patients with unresectable or metastatic melanoma who no longer respond to other drugs (OT 1/25/15 issue).


"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," Richard Pazdur, MD, Director of the FDA's Office of Hematology and Oncology Products, said in a news release. "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."


Opdivo was reviewed under the FDA's priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness in the treatment of a serious condition.


Opdivo has been approved more than three months ahead of its prescription drug user fee goal date when the FDA was scheduled to complete its review of the application.


The drug was evaluated in a randomized trial of 272 patients with squamous NSCLC. Overall survival for patients receiving Opdivo was an average 3.2 months longer than for patients receiving docetaxel.


Additionally, safety and efficacy for the drug were evaluated in a single-arm trial of 117 patients with squamous NSCLC who had progressed after receiving a platinum-based therapy and at least one additional systemic regimen. Fifteen percent of the patients receiving the drug had their tumors shrink or disappear, and 59 percent of the patients had a response lasting six months or longer.


The most common side effects for Opdivo are fatigue, shortness of breath, musculoskeletal pain, decreased appetite, cough, nausea, and constipation. The most serious side effects are severe immune-mediated side effects involving healthy organs, including the lung, colon, liver, kidneys, and hormone-producing glands.