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FDA Approves Akeso’s Penpulimab for Nasopharyngeal Carcinoma

The FDA approval is based on the international Phase III clinical trial AK105-304 and the pivotal AK105-202 study.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has approved Akeso Inc.’s differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). The FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and with least one other prior ...

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