The UK Medicines and Healthcare products Regulatory Agency (MHRA) has 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 tumors grow.

The medicine is given as an intravenous infusion over 1 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, Executive Director—Healthcare Quality and Access, MHRA, 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 (RBCs)), thrombocytopenia (low levels of blood platelets) and neutropenia.