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.
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鈥檚 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: 鈥淏eyond reaching our first international regulatory milestone, this approval also provides an important immunotherapy treatment option for patients with NPC in the US.
鈥淭he FDA approval of penpulimab-kcqx not only highlights the quality of our innovation but also underscores Akeso鈥檚 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.鈥�
Before this approval, the agency granted the antibody orphan drug, fast track and breakthrough therapy designations to treat NPC.
Akeso and Chia Tai-Tianqing 天美传媒app Group鈥檚 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.
