The Food and Drug Administration (FDA) has approved Opdivo (nivolumab; Bristol-Myers Squibb) for the treatment of advanced (metastatic) non-squamous non-small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based therapy. In addition, the FDA has approved Dako North America Inc.’s PD-L1 IHC 28-8 pharmDx test to detect PD-L1 protein expression levels and aid clinicians in assessing which patients may benefit most from treatment with Opdivo.

The safety and efficacy of Opdivo was shown in an international, open-label, randomized study (n=582) of patients with advanced NSCLC whose disease progressed during or after treatment with platinum-based chemotherapy and approrpriate biologic therapy. Patients were treated with Opdivo or docetaxel. The study’s primary endpoint was overall survival, and the secondary endpoint was objective response rate. Patients treated with Opdivo lived an average of 12.2 months vs. 9.4 months in patients treated with docetaxel. Also, 19% of patients treated with Opdivo experienced a complete or partial shrinkage of their tumors lasting an average of 17 months vs. 12% of patients treated with docetaxel, lasting an average of 6 months.

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The approval of the pharmDx test was based on an evaluation of samples from a subgroup of patients’ tumors that suggested PD-L1 levels in NSCLC tumors may help detect patients who are more likely to live longer due to treatment with Opdivo.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is approved as monotherapy for patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor; and for the treatment of patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy.

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