Drug Information Update – FDA expands approved use of drug to include advanced lung cancer

Drug Information Update – FDA expands approved use of drug to include advanced lung cancer
FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.

Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015. The most common type of lung cancer, non-small cell lung cancer (NSCLC), is further divided into two main types named for the kinds of cells found in the cancer – squamous cell and non-squamous cell (which includes adenocarcinoma).Opdivo works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Opdivo may help the body’s immune system fight the 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. Today’s approval expands the use of Opdivo to also treat patients with non-squamous NSCLC.

The most common side effects of Opdivo are fatigue, musculoskeletal pain, decreased appetite, cough and constipation. Opdivo also has the potential to cause serious side effects that result from the immune system effect of Opdivo (known as “immune-mediated side effects”). These severe immune-mediated side effects involve healthy organs, including the lung, colon, liver, kidneys, hormone-producing glands and the brain.

For more information, please visit: Opdivo

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