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FDA Approves Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Platinum-Containing Chemotherapy

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The U.S. Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda), an anti­–PD-1 (programmed cell death protein 1) therapy, at a fixed dose of 200 mg every 3 weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy.

Under the FDA’s accelerated approval regulations, this indication for pembrolizumab is approved based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. For patients with head and neck squamous cell carcinoma, PD-L1 (PD-1 ligand) testing is not needed prior to the use of pembrolizumab.

The approval is based on data from the KEYNOTE-012 study, which included patients with recurrent or metastatic head and neck squamous cell carcinoma who had disease progression on or after platinum-containing chemotherapy or following platinum-containing chemotherapy administered as part of induction, concurrent, or adjuvant therapy and ECOG performance status of 0 or 1. The data showed an objective response rate of 16% and complete response rate of 5%, with responses of 6 months or longer observed in 82% of the responding patients (n = 23/28). Objective response rate and duration of response were similar regardless of human papillomavirus status.

Immune-mediated adverse reactions occurred with pembrolizumab, including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.

“Today’s approval represents a meaningful advance for the oncology community, as well as for our head and neck cancer clinical program,” said Roger M. Perlmutter, MD, PhD, President, Merck Research Laboratories. “Together with prior approvals in the treatment of other tumor types, today’s action by the FDA underscores our tireless commitment to addressing the unmet needs of patients suffering from a broad range of cancers.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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