The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Accord Healthcare’s Henlius-partnered Hetronifly (serplulimab) as the first anti-PD-1 monoclonal antibody for an aggressive form of lung cancer.
The drug has been authorised to treat adults with extensive-stage small cell lung cancer (SCLC) that has not previously been treated and has spread within the lungs or to other parts of the body.
SCLC, a fast-growing cancer that typically develops in the airways of the lungs, accounts for up to 15% of all lung cancer cases and is often diagnosed at a late stage.
Administered as an intravenous infusion, Hetronifly is designed to block the PD-1 protein to help immune cells recognise and destroy cancer cells more effectively.
The approval was supported by positive results from the phase 3 ASTRUM-005 trial of 585 adults, who were randomised to receive either Hetronifly or placebo, alongside chemotherapy.
Hetronifly-treated patients lived on average for 15.4 months, compared with 10.9 months for those receiving chemotherapy and placebo.
Julian Beach, interim executive director of healthcare quality and access at the MHRA, said: “As the first and only anti-PD-1 monoclonal antibody approved in the UK for SCLC, this marks an important new treatment option for patients with this aggressive type of lung cancer who currently have limited choices and face a poor prognosis.
“We’re assured that the appropriate regulatory standards of safety, quality and efficacy for the approval of this medicine have been met. As with all products, we will keep its safety under close review.”
Serplulimab was originally developed by Henlius Biotech, which has granted Accord’s parent company Intas Pharmaceuticals exclusive rights to develop and commercialise the drug in over 50 countries across Europe and India.
The MHRA’s decision comes just under six months after it approved Amgen’s antineoplastic agent Imdylltra (tarlatamab) to treat SCLC in adults whose disease has spread throughout the lungs, to other parts of the body, or both, and who have failed two other types of treatments.