Squamous cell carcinoma of the head and neck (SCCHN) is an anatomically and biologically heterogeneous disease that has historically proven to be a complex challenge for drug development. In recent years, considerable advancements have been made, predominantly due to the emergence of immune checkpoint inhibitors. Merck & Co.’s Keytruda became the first immune checkpoint inhibitor to receive FDA approval in 2016, and it was the first new drug approved for SCCHN since Eli Lilly/Merck KGaA/Bristol-Myers Squibb’s Erbitux over ten years previously. Bristol-Myers Squibb’s PD-1 inhibitor Opdivo also received FDA approval in 2016, and EC and MHLW approvals followed in 2017, for previously treated metastatic or recurrent SCCHN. Clinical trials are now evaluating the role of immune checkpoint inhibitors in earlier stages of the disease, and several agents in this class are being positioned for the untapped and lucrative locoregionally advanced SCCHN setting, which is set to contribute to robust market growth throughout the 2017-2027 forecast period.
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