The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new drug for non-small cell lung cancer (NSCLC) via a national procedure.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new drug for non-small cell lung cancer (NSCLC) via a national procedure. The international unbranded name of the new drug is sugemalimab, to be sold under the brand name Eqjubi in the UK and known as Cejemly elsewhere.
Most lung cancers fall under the umbrella of NSCLC, which accounts for 80–85% of lung cancers, while small-cell lung cancer affects only about 15% of people with lung cancer. A recent, randomised, double-blind trial showed the efficacy of sugemalimab as a first-line treatment for metastatic NSCLC in combination with platinum-based chemotherapy compared with chemotherapy alone and placebo. Metastatic NSCLC is cancer which originates in the large cells of the lungs and then spreads elsewhere in the body. There are about 47,000 diagnoses of NSCLC in the UK every year.
Cancer cells can contain a protein called programmed death-ligand 1 (PD-L1), which can prevent immune cells from recognising cancer cells as a threat and eliminating them. Sugemalimab works by blocking PD-L1, thereby allowing the body’s natural immune cells to recognise and destroy cancer cells. The findings from the trial showed an improvement both in the length of time before patients’ cancer worsened and length of life. It is delivered to patients every three weeks via a drip.
Sugemalimab was approved by the Chinese National Medical Products Administration (NMPA) in 2022 and by the European Medicines Agency in July 2024. The MHRA followed recently, approving the drug for use in the UK on 30 October 2024. According to the manufacturer, the US Food & Drug Administration (FDA) has granted Orphan Drug Designation and Breakthrough Therapy Designation to sugemalimab, but it has not yet given a statement to this effect.
Some side effects were reported during the trial, and the MHRA is encouraging patients taking sugemalimab to report any side effects via the Yellow Card scheme, as well as reporting them to their doctor, nurse or pharmacist. More information can be found in the summary of product characteristics on the drug, published by the MHRA in November 2024.
