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FDA expands approval of Opdivo for advanced nonsquamous NSCLC
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The FDA today expanded the approval of nivolumab to include patients with metastatic nonsquamous non–small cell lung cancer whose disease progressed on or after platinum-based chemotherapy.
Nivolumab (Opdivo, Bristol-Myers Squibb) was approved in conjunction with the PD-L1 IHC 28-8 pharmDx test (Dakota North America) to detect PD-L1 protein expression levels and help physicians select patients most likely to benefit from therapy.
The FDA based its decision in part on results of a randomized study that included 582 patients with advanced NSCLC. Patients who received nivolumab achieved longer OS — the study’s primary endpoint — than patients assigned docetaxel (12.2 months vs. 9.4 months). Nineteen percent of patients treated with nivolumab experienced complete or partial shrinkage of tumors — which lasted an average of 17 months — compared with 12% of patients treated with docetaxel.
“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,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”
In March, the FDA approved nivolumab for the treatment of patients with metastatic squamous NSCLC.
The FDA approved nivolumab for the nonsquamous indication 3 months ahead of the prescription drug user fee goal date of Jan. 2.