FDA Expands Approved Use of Nivolumab to Squamous NSCLC

New indication concerns treatment of metastatic squamous NSCLC with progression on or after platinum-based chemotherapy

On 4 March, 2015, the US Food and Drug Administration (FDA) expanded the approved use of nivolumab (Opdivo) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Nivolumab is a PD-1 pathway inhibitor.

Nivolumab’s efficacy to treat squamous NSCLC was established in a randomised trial of 272 participants, of whom 135 received nivolumab and 137 received docetaxel. The trial was designed to measure the overall survival. On average, participants who received nivolumab lived 3.2 months longer than those participants who received docetaxel.

 “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 Dr Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The safety and efficacy of nivolumab to treat squamous NSCLC was supported by a single-arm trial of 117 participants who had progressed after receiving a platinum-based therapy and at least one additional systemic regimen. The study was designed to measure objective response rate (ORR). Results showed 15% of participants experienced ORR, of whom 59% had response durations of six months or longer.   

The most common side effects of nivolumab are fatigue, shortness of breath, musculoskeletal pain, decreased appetite, cough, nausea and constipation. The most serious side effects are severe immune-mediated side effects involving healthy organs, including the lung, colon, liver, kidneys and hormone-producing glands.  

Nivolumab for squamous NSCLC was reviewed under the FDA’s priority review programme, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness in the treatment of a serious condition. Nivolumab is being approved more than three months ahead of the prescription drug user fee goal date of 22 June, 2015, the date when the agency was scheduled to complete its review of the application.

The FDA previously approved nivolumab to treat patients with unresectable or metastatic melanoma who no longer respond to other drugs.

Opdivo is marketed by Princeton, New Jersey-based Bristol-Myers Squibb.