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FDA expands Opdivo use for a few NSCLC patients

“While Opdivo showed an overall survival benefit in certain [NSCLC] patients, it appears that higher expression of PD-L1 in a patient’s tumor predicts those most likely to benefit”.

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The drug can now be used on patients whose non-small cell lung cancer metastasized while undergoing platinum-based chemotherapy or after.

Bristol-Myers Squibb Co.’s immune cancer therapy won approval from USA regulators for a broader population of lung cancer patients, a boost for a drug that’s expected to become a blockbuster.

In regards to the specific test and its results, Quest Diagnostics general manager Christopher Fikry, MD, comments, “Lung cancer is the leading cause of cancer-related deaths, yet has traditionally been very hard to combat with conventional therapies”. Participants were given either nivolumab or docetaxel.

In the USA, the PD-1 checkpoint inhibitor was first approved in December a year ago as a second-line treatment for advanced melanoma, followed by a green light in March in the squamous NSCLC setting. Patients who received nivolumab achieved longer OS – the study’s primary endpoint – than patients assigned docetaxel (12.2 months vs. 9.4 months). 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. According to the FDA statement, patients treated with nivolumab lived longer and experienced more tumor shrinkage than those who were treated with docetaxel. The addition of the PD-L1 test to Quest’s oncology diagnostics arsenal will give physicians greater understanding of treatment expectations with OPDIVO®, a new treatment option, and helpful information to communicate to patients.

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The most common side effects associated with Opdivo are fatigue, musculoskeletal pain, decreased appetite, cough and constipation.

Nivolumab Approved for Advanced Lung Cancer