← All approvals · Cancer · 2025
penpulimab-kcqx (penpulimab-kcqx)
The FDA approved penpulimab-kcqx (penpulimab-kcqx) on April 23, 2025 In combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent while on or after platinum-based chemotherapy and at least one other prior line of therapy.
- Brand name
- penpulimab-kcqx
- Generic name
- penpulimab-kcqx
- FDA approval date
- April 23, 2025
- Approved use (FDA wording)
- In combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent while on or after platinum-based chemotherapy and at least one other prior line of therapy
- Company
- Akeso Biopharma
- Application
- BLA761258
- Dosage form / route
- INJECTABLE · INTRAVENOUS
- Boxed warning on label
- Not listed
- Category on this site
- Cancer
Indications and usage, from the FDA label
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) ( 1.1 ) 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. ( 1.2 ) 1.1 First-line Treatment of Recurrent or Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, in combination with either cisplatin or carboplatin and gemcitabine, is indicated for the first-line treatment…