On 23 September 2026, the Medicines and Healthcare products Regulatory Agency approved lurbinectedin, marketed as Zepzelca, for adults with extensive-stage small-cell lung cancer. The authorisation covers use with atezolizumab as maintenance treatment where a patient's disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. According to the MHRA, the new marketing authorisation was granted to Pharma Mar, S.A. The decision creates a new licensed option in a tightly defined treatment setting rather than a broad approval across all stages of small-cell lung cancer.
The scope of the approval is important. The medicine is positioned after initial treatment and alongside atezolizumab, not as a replacement for first-line chemotherapy and immunotherapy. That makes the decision relevant to oncologists managing the next phase of care once the first treatment block has been completed without disease progression. The MHRA says lurbinectedin is given by intravenous infusion over one hour, with the recommended dose administered once every 21 days. Treatment should be started and supervised in a hospital or clinic by a healthcare professional.
In its announcement, the MHRA said lurbinectedin works by attaching to DNA inside cancer cells. The regulator said this damages the DNA, interferes with cancer cell growth and multiplication, and contributes to cancer cell death. It also said the medicine reduces the activity of certain immune cells that help tumours grow. For readers outside oncology, that means the drug is intended to act directly on tumour biology while being used within an established maintenance regimen.
The evidence cited by the regulator came from a main study involving 483 adults with extensive-stage small-cell lung cancer. Patients who received lurbinectedin with atezolizumab as maintenance treatment lived for an average of 13.2 months, compared with 10.6 months for those who received atezolizumab alone. The same study found that patients receiving the combination lived for an average of 5.4 months without their disease worsening, compared with 2.1 months for patients receiving atezolizumab alone. Those figures formed the core evidence base for the MHRA's licensing decision.
Julian Beach, the MHRA's Executive Director of Healthcare Quality and Access, said the approval provides a new treatment option for adults whose disease has not progressed after initial therapy. He also said that, as with all licensed medicines, the agency will continue to monitor safety through the Yellow Card scheme. That continuing surveillance is a routine part of medicines regulation. It means the authorisation is paired with ongoing monitoring of suspected adverse reactions in real-world use.
The MHRA lists nausea, fatigue, anaemia, thrombocytopenia and neutropenia among the most common side effects reported with lurbinectedin. Patients who experience side effects are advised to speak to a doctor, pharmacist or nurse, and suspected side effects can also be reported through Yellow Card. The agency said the Summary of Product Characteristics and Patient Information Leaflet will be published on the MHRA products website within seven days of approval, giving clinicians and patients the formal prescribing and safety documents for the new indication.
The application was submitted and approved through the International Recognition Procedure Route B, with the European Medicines Agency acting as the reference regulator. According to the MHRA, that pathway was used when granting the UK authorisation. For policy readers, that procedural detail matters. It shows the regulator using an international reference route while still issuing a distinct UK marketing authorisation under its own decision-making framework.