The US Food and Drug Administration (FDA) has granted approval to Akeso’s differentiated programmed cell death protein 1 (PD-1) monoclonal antibody, penpulimab-kcqx.
The antibody is to treat adult recurrent or metastatic non-keratinising nasopharyngeal carcinoma (NPC) in conjunction with cisplatin or carboplatin and gemcitabine as a first-line treatment.
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Akeso’s antibody has also been approved as a monotherapy for treating the adult population with metastatic non-keratinising NPC who have experienced disease progression on or after platinum-based chemotherapy and have received a minimum of one other previous therapy line.
The approval is supported by the outcomes from the international randomised Phase III study AK105-304 and the pivotal AK105-202 trial, which backed the two biologics licence applications (BLA) for the antibody.
These trials have shown the clinical benefits as well as a favourable safety profile of the antibody across two stages of metastatic NPC treatment.
The approval aligns with the company’s global drug development strategy and its expansion offerings. It also provides a new immunotherapy alternative for individuals suffering from advanced NPC in the country.
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By GlobalDataAkeso CEO, president, founder and chairwoman Dr Yu Xia said: “Beyond reaching our first international regulatory milestone, this approval also provides an important immunotherapy treatment option for patients with NPC in the US.
“The FDA approval of penpulimab-kcqx not only highlights the quality of our innovation but also underscores Akeso’s focus on delivering treatments for difficult-to-treat cancers for patients around the world. We are deeply grateful to all the researchers, participants, and patients who have contributed to this success.”
Before this approval, the agency granted the antibody orphan drug, fast track and breakthrough therapy designations to treat NPC.
Akeso and Chia Tai-Tianqing Pharmaceutical Group’s joint venture has been instrumental in managing the further development and commercialisation of the antibody.
In China, the antibody has already been approved for two indications: as a first-line treatment of advanced NPC and as a second or further line treatment of the same condition.
