FDA Approves Nivolumab (Opdivo) for NSCLC

March 5, 2015

The FDA has approved nivolumab (Opdivo) for the treatment of metastatic squamous non-small-cell lung cancer (NSCLC) in patients who have progressed on a platinum-based chemotherapy.

The US Food and Drug Administration (FDA) has approved the anti–PD-1 drug nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of metastatic squamous non–small-cell lung cancer (NSCLC) in patients who have progressed on a platinum-based chemotherapy.

“The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available in late December 2014,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials.”

The trial that led to the approval was an open-label, multicenter, randomized trial that included 272 patients with metastatic squamous cell carcinoma whose disease had progressed following treatment with a platinum-based chemotherapy. Patients were randomized to either 3 mg/kg intravenous nivolumab (n = 135) every 2 weeks or 75 mg/m2 docetaxel (n = 137) every 3 weeks.

A pre-specified interim analysis showed that patients treated with nivolumab had improved overall survival compared with those treated with docetaxel (9.2 vs 6 months; hazard ratio = 0.59; 95% CI, 0.44–0.79; P = .00025).

Results of a single-arm trial of patients with metastatic squamous cell carcinoma (n = 117) treated with nivolumab was also submitted to the FDA. This trial showed that 17 patients (15%) responded to treatment, as measured by Response Evaluation Criteria in Solid Tumors (RECIST). All were partial responses. Among those who responded, 10 patients (59%) had responses that lasted 6 months or longer.

The most common adverse events (≥ 30%) among patients on nivolumab were decreased appetite, fatigue, cough, musculoskeletal pain, and dyspnea. The most frequent grade 3/4 adverse events (> 5%) were fatigue, musculoskeletal pain, and dyspnea.

Immune-mediated adverse events included colitis, hepatitis, hypothyroidism, hyperthyroidism, nephritis/renal dysfunction, and pneumonitis.

In December 2014, the FDA approved nivolumab for the treatment of  unresectable or metastatic melanoma in pretreated patients.