【FDA Approval Alert】Akeso’s penpulimab-kcqx Approved for Non-Keratinizing Nasopharyngeal Carcinoma (April 23, 2025)
On April 23, 2025, the U.S. FDA approved penpulimab-kcqx (Akeso) for adult patients with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). Approval includes both first-line use with platinum (cisplatin or carboplatin) plus gemcitabine and single-agent use after platinum-based chemotherapy and at least one additional prior line of therapy. The approval is based on the AK105-304 (NCT04974398) and AK105-202 (NCT03866967) trials.
Disease Overview: Non-Keratinizing Nasopharyngeal Carcinoma (NPC)
NPC is a malignancy prevalent in East Asia, particularly associated with Epstein-Barr virus infection in non-keratinizing subtypes. Immunotherapy has expanded treatment options for advanced stages.
Treatment Summary
- Drug Name: penpulimab-kcqx (Akeso)
- Company: Akeso Biopharma Co., Ltd.
- Approval Date: April 23, 2025
- Indications:
- First-line: with cisplatin or carboplatin plus gemcitabine
- Previously treated: monotherapy after platinum and one prior systemic therapy
- Mechanism of Action: Anti-PD-1 antibody (immune checkpoint inhibitor)
- Pivotal Trials:
- First-line: AK105-304 (NCT04974398)
- Previously treated: AK105-202 (NCT03866967)
- Key Efficacy:
- First-line: Median PFS 9.6 vs 7.0 months (HR 0.45; p<0.0001)
- Previously treated: ORR 28% (95% CI: 20–37), Median DOR not reached (≥9.2 months)
Patient-Friendly Summary
Penpulimab enhances immune function to suppress cancer progression and provides a new treatment option for both first-line and previously treated nasopharyngeal cancer patients.
M&A Information
- Subsidiary: Not applicable (Akeso in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (HKEX: 9926)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
