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Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC)

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  • The US FDA has approved penpulimab-kcqx + CT (cisplatin/carboplatin + gemcitabine) as 1L treatment for recurrent or metastatic non-keratinizing NPC in adults, & as monotx. for those with metastatic non-keratinizing NPC progressing on/after Pt-based CT & ≥1L prior therapy
  • Approval was supported by 2 BLA submissions based on international P-III (AK105-304) trial & pivotal AK105-202 study assessing penpulimab-kcqx across two stages of metastatic NPC; data to be presented at AACR 2025
  • Penpulimab-kcqx (PD-1 mAb) was initially developed by Akeso, with subsequent development & commercialization handled via a joint venture with Chia Tai-Tianqing Pharmaceutical Group

Ref: PRNewswire | Image: Akeso

Related News:- Akeso Reports First Patient Enrollment in P-III Study of Ivonescimab + CT to Treat Triple-Negative Breast Cancer (TNBC) in China

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