The Medicines and Healthcare products Regulatory Agency has approved lurbinectedin (Zepzelca) for use in combination with atezolizumab as a maintenance treatment for adults with extensive-stage small cell lung cancer (SCLC) whose disease has not progressed following first-line induction therapy.
The decision marks an important development for patients with one of the most aggressive forms of lung cancer, offering a new treatment option after initial therapy with atezolizumab, carboplatin and etoposide.
Lurbinectedin is designed to target cancer cells by binding to DNA and disrupting the processes that enable tumour growth. By damaging cancer cell DNA, the treatment interferes with cell replication and ultimately causes cancer cell death. It also helps suppress the activity of certain immune cells that can support tumour development.
The medicine is administered through a one-hour intravenous infusion every 21 days and must be initiated and supervised by healthcare professionals in a hospital or clinic setting.
The MHRA's approval was based on data from a clinical study involving 483 adults with extensive-stage SCLC.
Results showed that patients receiving lurbinectedin alongside atezolizumab as maintenance therapy achieved an average overall survival of 13.2 months, compared with 10.6 months among patients receiving atezolizumab alone.
The study also demonstrated a significant improvement in progression-free survival. Patients treated with the combination therapy lived an average of 5.4 months without their disease worsening, compared with 2.1 months for those receiving only atezolizumab.
These findings suggest the combination could help extend both overall survival and the period before disease progression in a patient population where treatment options remain limited.
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 frequently reported side effects associated with lurbinectedin include:
- Nausea
- Fatigue
- Anaemia
- Thrombocytopenia (low platelet count)
- Neutropenia
Patients experiencing side effects are advised to consult their doctor, pharmacist or specialist nurse. Suspected adverse reactions can also be reported through the MHRA's Yellow Card scheme, which continues to play a crucial role in monitoring the safety of medicines across the UK.
The approval introduces an additional maintenance treatment option for patients with extensive-stage SCLC, a cancer type known for rapid progression and high recurrence rates. Healthcare leaders and oncology teams will be closely watching how the therapy is incorporated into clinical pathways and future treatment guidelines across the NHS.
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