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Akeso Wins US Approval For PD-1 Antibody In NPC, Partly On US Data

 
• By Dexter Jie Yan

Akeso’s penpulimab will be the second to hit the US market for nasopharyngeal carcinoma, but the first to win FDA approval for the indication based on clinical findings in US patients.

Nasopharyngeal carcinoma is a rare form of head and neck cancer in western populations. (Shutterstock)

Akeso has garnered a regulatory nod for penpulimab from the US Food and Drug Administration, making the agent the second PD-1 checkpoint inhibitor originating from a Chinese drug maker in the US market for nasopharyngeal carcinoma (NPC), a rare form of head and neck cancer in mostly Western populations.

Akeso generated the first positive clinical evidence worldwide supporting the first-line use of an anti-PD-1/L1 agent in this form of...

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Pipeline Watch: 12 Approvals And 26 Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.