MHRA: Lurbinectedin Approved for Small Cell Lung Cancer

We use some essential cookies to make this website work. We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. We also use cookies set by other sites to help us deliver content from their services. You have accepted additional cookies. You can change your cookie settings at any time. You have rejected additional cookies. You can change your cookie settings at any time. As with all licensed medicines, the MHRA will keep the safety and effectiveness of lurbinectedin under close review. The Medicines and Healthcare products Regulatory Agency (MHRA) has today (23 September 2026) approved lurbinectedin (Zepzelca) for the treatment of adults with extensive-stage small cell lung cancer (SCLC), in combination with atezolizumab as maintenance treatment in adults whose cancer has not progressed following first-line induction therapy with atezolizumab, carboplatin, and etoposide. Lurbinectedin works by attaching to DNA inside cancer cells. This damages the DNA and interferes with the growth and multiplication of cancer cells, leading to cancer cell death. It also reduces the activity of certain immune cells that help tumours grow. The medicine is given as an intravenous infusion over one hour. The recommended dose is administered once every 21 days. Treatment should be started and supervised in a hospital or clinic by a healthcare professional. This approval was based on a main study involving 483 adults with extensive-stage SCLC. Patients receiving lurbinectedin in combination with atezolizumab as maintenance treatment lived for an average of 13.2 months, compared with 10.6 months for those receiving atezolizumab alone. Patients receiving lurbinectedin plus atezolizumab also lived for an average of 5.4 months without their disease getting worse, compared with 2.1 months for those receiving atezolizumab alone. Julian Beach, MHRA Executive Director of Healthcare Quality and Access, said: The approval of lurbinectedin provides a new treatment option for adults with extensive-stage small cell lung cancer whose disease has not progressed following initial treatment with atezolizumab, carboplatin, and etoposide. As with all licensed medicines, we will continue to monitor its safety through the UK Yellow Card scheme and encourage patients and healthcare professionals to report any suspected side effects. The most common side effects with lurbinectedin include nausea, fatigue (tiredness), anaemia (low levels of red blood cells), thrombocytopenia (low levels of blood platelets) and neutropenia. Patients who experience side effects should speak to their doctor, pharmacist or nurse. Suspected side effects can also be reported through the MHRA’s Yellow Card scheme. The new marketing authorisation was granted on 23 September 2026 to Pharma Mar, S.A. More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval. This product was submitted and approved via the International Recognition Procedure (IRP) Route B with the European Medicines Agency (EMA) acting as the Reference Regulator. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is an executive agency of the Department of Health and Social Care. For media enquiries, please contact the newscentre@mhra.gov.uk , or call on 020 3080 7651. The following links open in a new tab Share on Facebook (opens in new tab) Share on X (opens in new tab) Is this page useful? Maybe Yes this page is useful No this page is not useful Thank you for your feedback Report a problem with this page Help us improve GOV.UK Do not include personal or financial information like your Nati