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A new treatment has been approved for extensive-stage small cell lung cancer

by · Open Access Government

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved lurbinectedin (Zepzelca) as a new treatment option for adults with extensive-stage small cell lung cancer (SCLC)

The approval, announced on 23 September 2026, applies to patients whose cancer has not progressed following initial treatment with atezolizumab, carboplatin and etoposide. Lurbinectedin will be used alongside atezolizumab as a maintenance treatment.

Evidence from clinical study

The MHRA’s decision was supported by a main clinical study involving 483 adults with extensive-stage SCLC.

Patients who received lurbinectedin in combination with atezolizumab lived for an average of 13.2 months. This compared with 10.6 months among those who received atezolizumab alone.

The combination treatment also extended the period patients lived without their cancer getting worse. On average, this was 5.4 months for patients receiving lurbinectedin and atezolizumab, compared with 2.1 months for those receiving atezolizumab alone.

These results formed the basis for regulatory approval of the treatment in this patient group.

How lurbinectedin works

Lurbinectedin is a targeted cancer medicine that attaches to DNA inside cancer cells. This damages the DNA and interferes with the cells’ ability to grow and multiply, which can ultimately lead to cancer cell death.

The medicine can also reduce the activity of certain immune cells that are involved in supporting tumour growth.

Treatment given every three weeks

Lurbinectedin is administered through an intravenous infusion, which takes about one hour. The recommended treatment is given once every 21 days.

An appropriately qualified healthcare professional should start and supervise treatment in a hospital or clinic.

The approval is specifically for adults with extensive-stage SCLC whose disease has remained stable or responded following first-line treatment with atezolizumab, carboplatin and etoposide.

Side effects and safety monitoring

The most common side effects associated with lurbinectedin include nausea, fatigue, anaemia, thrombocytopenia and neutropenia.

Anaemia involves low red blood cell levels, while thrombocytopenia refers to low blood platelet levels. Neutropenia is a reduction in a type of white blood cell that plays an important role in fighting infections.

The MHRA will continue to monitor the safety and effectiveness of lurbinectedin following its approval. Patients and healthcare professionals are encouraged to report suspected side effects through the UK’s Yellow Card scheme.