India, April 24 -- Akeso Inc. announced that the U.S. Food and Drug Administration has approved its 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 line of therapy.
Akeso noted that Penpulimab-kcqx was developed independently by Akeso, with further development and commercialization managed through a joint venture with Chia Tai-Tianqing Pharmaceutical Group.
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