Magazine article American Nurse Today

FDA Expands Approved Use of Opdivo in Advanced Lung Cancer: Opdivo Demonstrates Survival Benefit in Squamous and Non-Squamous Non-Small Cell Lung Cancer

Magazine article American Nurse Today

FDA Expands Approved Use of Opdivo in Advanced Lung Cancer: Opdivo Demonstrates Survival Benefit in Squamous and Non-Squamous Non-Small Cell Lung Cancer

Article excerpt

For Immediate Release

October 9, 2015

Release

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 oflung 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.

"There is still a lot to learn about the PD-1/PD-L1 pathway and its effects in lung cancer, as well as other tumor types," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "While Opdivo showed an overall survival benefit in certain non-small cell lung cancer patients, it appears that higher expression ofPD-Ll in a patient's tumor predicts those most likely to benefit."

The safety and effectiveness of Opdivo for this use was demonstrated in an international, open-label, randomized study of 582 participants with advanced NSCLC whose disease progressed during or after treatment with platinum-based chemotherapy and appropriate biologic therapy. Participants were treated with Opdivo or docetaxel. The primary endpoint was overall survival, and the secondary endpoint was objective response rate (the percentage of patients who experienced complete or partial shrinkage of their tumors). Those treated with Opdivo lived an average of 12.2 months compared to 9.4 months in those treated with docetaxel. Additionally, 19 percent of those treated with Opdivo experienced a complete or partial shrinkage of their tumors, an effect that lasted an average of 17 months, compared to 12 percent among those taking docetaxel, which lasted an average of six months.

While patients who received Opdivo lived longer than those who received docetaxel across the study, an evaluation of samples from a subgroup of patients' tumors suggests that the level ofPD-L1 expression in NSCLC tumors may help identify patients who are more likely to live longer due to treatment with Opdivo. …

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