FDA approves penpulimab-kcqx for NP carcinoma

The US Food and Drug Administration (FDA) approved penpulimab-kcqx, from little known Chinese biotech Akeso Biopharma (HKEX: 9926), with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with 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 at least one other prior line of therapy.

This application was granted fast track designation, breakthrough designation, and orphan drug designation.