The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pharma Mar’s lurbinectedin (Zepzelca) to treat adults with extensive-stage small cell lung cancer (SCLC).
The treatment is 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 treatment is given as an intravenous infusion over one hour. The recommended dose is administered once every 21 days.
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 Interim 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.