Bristol-Myers: FDA Expands Approval Of Opdivo To Treat Lung Cancer

(RTTNews) - Bristol-Myers Squibb Co (BMY) on Wednesday said the U.S. Food and Drug Administration (FDA) has expanded the approved use of Opdivo (nivolumab) to treat patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.

Opdivo (nivolumab) injection, for intravenous use, is the first and only PD-1 (programmed death receptor-1) therapy to demonstrate overall survival in previously treated metastatic squamous non-small cell lung cancer (NSCLC), the company said.

Opdivo demonstrated significantly superior overall survival (OS) vs. docetaxel, with a 41% reduction in the risk of death in a prespecified interim analysis of a Phase III clinical trial. The median OS was 9.2 months in the Opdivo arm and 6 months in the docetaxel arm.

Lung cancer is the leading cause of cancer death in the United States, with an estimated 224,210 new diagnoses and 159,260 deaths in 2014. The most common type of lung cancer, NSCLC affects seven out of eight lung cancer patients, occurring when cancer forms in the cells of the lung.

Opdivo works by inhibiting the cellular pathway known as PD-1 protein on cells that blocks the body's immune system from attacking cancerous cells.

The most common side effects of 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.

Opdivo for squamous NSCLC was reviewed under the FDA's priority review program. Opdivo is being approved more than three months ahead of the prescription drug user fee goal date of June 22, the date when the agency was scheduled to complete its review of the application.

The FDA previously approved Opdivo to treat patients with unresectable (cannot be removed by surgery) or metastatic melanoma who no longer respond to other drugs.