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# FDA OKs Akeso’s Nasopharyngeal Cancer Therapy
- URL: https://www.fdaweb.com/fda-oks-akesos-nasopharyngeal-cancer-therapy/
- Published: 2025-04-24T12:00:00.000Z
- Updated: 2026-09-14T15:10:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159065

FDA has approved an Akeso Biopharma BLA for penpulimab-kcqx, indicated for adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). The approval covers penpulimab in combination with platinum-based chemotherapy (either cisplatin or carboplatin) and gemcitabine as a first-line treatment for adults with recurrent or metastatic NPC. Additionally, the drug has been approved as a standalone treatment for patients whose disease has progressed after platinum-based chemotherapy and at least one other line of therapy, according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma?utm%5Fmedium=email&utm%5Fsource=govdelivery).

The approval is based on data from two key clinical trials. The first, Study AK105-304, showed that patients receiving the penpulimab-based combination therapy saw a median progression-free survival of 9.6 months, compared to 7.0 months for those in the placebo group, FDA says. After 12 months, 31% of patients in the penpulimab group remained progression-free, compared to just 11% in the placebo group.

The other study, AK105-202, focused on penpulimab as a single agent and showed an objective response rate of 28% in patients treated with the therapy, with many experiencing durable responses, although the median duration of response had not yet been reached at the time of analysis, according to the agency.

FDA says that common side effects included nausea, fatigue, hypothyroidism, and rash, among others. Serious immune-related adverse reactions were also reported, including pneumonitis, colitis, and hepatitis. Fatal events occurred in approximately 1% of patients.