The Medicines and Healthcare products Regulatory Agency (MHRA) has approved CStone Pharmaceuticals’ sugemalimab as part of a first-line combination treatment for lung cancer.
The anti-PD-L1 monoclonal antibody has been authorised under the brand name Eqjubi for use alongside platinum-based chemotherapy to treat adults with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic alterations.
The approval was supported by positive results from the late-stage GEMSTONE-302 study, in which sugemalimab in combination with chemotherapy significantly prolonged progression-free survival and overall survival compared to placebo plus chemotherapy in treatment-naïve patients with metastatic NSCLC.
Julian Beach, MHRA interim executive director of healthcare quality and access, said: “We’re assured that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this new formulation have been met. As with all products, we will keep its safety under close review.”
Approximately 49,200 people are diagnosed with lung cancer every year in the UK, with NSCLC accounting for up to 85% of cases.
Sugemalimab is designed to block the PD-1 protein, stopping cancer from switching off immune cells and increasing the immune system’s ability to kill cancer cells. The drug is administered in a hospital or clinic every three weeks through a 60-minute infusion into the vein.
The MHRA’s decision comes just a few months after the European Commission approved sugemalimab under the brand name Cejemly for the same indication.
Jason Yang, chief executive officer, president of research and development, and executive director of the board at CStone, described the latest approval of the drug as a “significant milestone in [the company’s] global expansion strategy”.
Yang added that CStone is “communicating with the European Medicines Agency and other agencies for additional regulatory applications for other sugemalimab indications, including stage 3 NSCLC, first-line gastric cancer and first-line oesophageal squamous cell carcinoma”.
CStone also recently announced that the population pharmacokinetics modelling results of sugemalimab had been published in the British Journal of Clinical Pharmacology.