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The FDA has accepted for review a biologics license application for the use of toripalimab in combination with gemcitabine and cisplatin in the frontline treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma, and for use as a single agent in the second- or later-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma following platinum-containing chemotherapy.

Patricia Keegan, MD

The rolling submission of a biologics license application to support the approval of both toripalimab plus gemcitabine- and cisplatin-based chemotherapy as a first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma, as well as toripalimab monotherapy for the second-line or beyond treatment of patients with recurrent or metastatic nasopharyngeal carcinoma after platinum-based chemotherapy has been completed.