Akeso Announces FDA Approval for Penpulimab-kcqx in Two BLA Indications for Comprehensive Treatment of Advanced Nasopharyngeal Carcinoma

Akeso Announces FDA Approval for Penpulimab-kcqx in Two BLA Indications for Comprehensive Treatment of Advanced Nasopharyngeal Carcinoma

HONG KONG, April 24, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the U.S. Food and Drug Administration (FDA) has approved its differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin…

New PD-1 Inhibitor Approved for Nasopharyngeal Carcinoma

(MedPage Today) -- The FDA approved the PD-1 inhibitor penpulimab, with two indications, for treating non-keratinizing nasopharyngeal carcinoma (NPC) in adults. No trade name was indicated for the drug. The first indication -- for the first...

FDA approves Akeso's antibody for nasopharyngeal carcinoma

The FDA has granted approval to Akeso's differentiated programmed cell death protein 1 (PD-1) monoclonal antibody, penpulimab-kcqx,

FDA Approves Akeso’s Penpulimab for Dual Use in Nasopharyngeal Cancer Treatment

HONG KONG, April 25, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the U.S. Food and Drug Administration (FDA) has approved its differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a …

FDA Approves Penpulimab for Nasopharyngeal Cancer

Penpulimab is approved for multiple indications in China, but this marks the first US approval for the novel monoclonal antibody. Medscape Medical News

FDA Approves Penpulimab-Kcqz for Indications in Nonkeratinizing Nasopharyngeal Carcinoma

The treatment received indications as a monotherapy and in combination regimen with carboplatin or cisplatin and gemcitabine.