FDA Approves Pembrolizumab for Recurrent/Metastatic Head and Neck Cancer

The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab, a PD-1 receptor inhibitor, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have experienced disease progression on or after platinum-containing therapy.¹

Approval was based on findings from an international, open-label, multi-cohort study, which evaluated 2 doses and schedules of pembrolizumab in 174 patients with recurrent or metastatic head and neck squamous cell carcinoma.

Of those, 16% (95% CI, 11-22) achieved an objective response as determined by an independent review committee.

Median duration of response was not reached at the time of analysis, but response durations ranged from 2.4 months to 27.7 months. Among the 28 patients who achieved a response, 82% had a response lasting 6 months or longer.

The most common adverse reactions in this patient population were fatigue, decreased appetite, and dyspnea.

The safety profile was similar to that seen with melanoma or non-small cell lung cancer treated with pembrolizumab, though an increased incidence of facial edema and new or worsening hypothyroidism were observed in patients treated for head and neck cancer.

The recommended dose and schedule of pembrolizumab for head and neck cancer is 200 mg given intravenously over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.                            

Reference

1. Pembrolizumab (Keytruda). U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm515627.htm. Updated August 5, 2016. Accessed August 9, 2016.