On June 1, 2026 PharmaMar (MSE: PHM), reported that the European Commission (EC) has approved the combination of Zepzelca (lurbinectedin) with atezolizumab (Tecentriq) as a first-line maintenance treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed following standard induction therapy. This approval follows the positive opinion issued on March 27th by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) concerning this treatment.
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Luis Mora, Managing Director of PharmaMar, points out that "it is great news that European patients and doctors now have access to a new treatment for this type of cancer. We believe it has the potential to change the paradigm of treatment for this disease, so we are looking forward to it being available soon in hospitals across Europe."
The approval is based on data from the Phase 3 IMforte trial, sponsored by Roche in collaboration with Jazz Pharmaceuticals, in which the combination of lurbinectedin and atezolizumab as maintenance treatment in first-line ES-SCLC was associated with a 46% reduction in the risk of disease progression or death and a 27% reduction in the risk of death compared with atezolizumab monotherapy.
In addition, lurbinectedin has been approved as an orphan drug, a designation granted by the EMA to medicines intended for the treatment of rare or uncommon diseases affecting fewer than 5 people per 10,000 inhabitants in the European Union.
Each year, around 62,000 new cases of SCLC are diagnosed in Europe, with most patients presenting advanced disease at the time of diagnosis .
Lurbinectedin in combination with atezolizumab has already been approved in 13 other countries, including the United States, for first-line maintenance treatment of this disease.
(Press release, PharmaMar, JUN 1, 2026, View Source [SID1234666317])