Treats recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) as a…. BLA 761258, held by Akeso Biopharma. Penpulimab-Kcqx.
As of Nov 13, 2026, BLA 761258 (Penpulimab-Kcqx), held by Akeso Biopharma, was first approved by FDA on Apr 23, 2025, with 1 approved supplement and 1 published complete response letter.
Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody indicated: in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 23, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jan 19, 2024 | AK105Clinical, Product Quality, Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Penpulimab-Kcqx100MG/10ML(10MG/ML) · injectable;intravenous | Penpulimab-Kcqx | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2026 | Supplement 2Labeling · Standard review | Approved | |
| Apr 23, 2025 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
