Akeso’s Penpulimab Approved for First-Line Nasopharyngeal Cancer Treatment
Monday, March 17, 2025
Akeso has received approval from China’s National Medical Products Administration (NMPA) for the use of its anti-PD-1 monoclonal antibody, penpulimab, as a first-line treatment for recurrent or metastatic nasopharyngeal cancer (NPC) in combination with chemotherapy.
Penpulimab was previously approved for third-line treatment in advanced NPC.
With this latest approval, the drug now offers a treatment option across different stages of the disease, providing continuous immunotherapy from first-line to third-line treatment.
Nasopharyngeal cancer remains a prevalent condition in certain regions, with a high clinical need for effective treatment options. Penpulimab, classified as an IgG1 subtype anti-PD-1 monoclonal antibody, has demonstrated strong efficacy in clinical trials.
It has shown a high response rate and prolonged survival benefits in patients receiving first-line treatment for NPC, as well as those with metastatic NPC who have undergone multiple prior treatments.
Additionally, the drug has demonstrated a favourable safety profile with a lower incidence of immune-related adverse effects.
This marks the fourth approved indication for penpulimab.
In addition to NPC, the drug is authorised for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) when used with chemotherapy and as a monotherapy for relapsed or refractory classical Hodgkin lymphoma (cHL) in patients who have undergone at least two previous systemic treatments.
A supplemental New Drug Application (sNDA) is also under review for the use of penpulimab in combination with anlotinib for the first-line treatment of advanced hepatocellular carcinoma (HCC).
Source: akesobio.com
