The Swiss Agency for Therapeutic Products (Swissmedic) has granted the temporary approval marketing Zepzelca® (lurbinectedin), from PharmaMar (MSE:PHM), for the treatment of adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy without central nervous system metastases.
This new approval of lurbinectedin is based on clinical data from a single-arm, multicenter, open-label, monotherapy trial conducted in 105 adult patients with recurrent metastatic small cell lung cancer (including patients with platinum-sensitive, platinum-resistant, and platinum-refractory disease), which the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the United States.
The temporary authorization is granted under certain conditions defined by law to make medicines available to patients as soon as possible for the treatment of life-threatening diseases with limited therapeutic options.
louis mora, CEO of PharmaMar’s Oncology and Virology Business Units, said: “We are pleased to announce to patients that Switzerland is the first country in Europe to approve lurbinectedin. It will be marketed directly by the PharmaMar team. This approval brings hope to many patients with metastatic small cell lung cancer in that country, who will now have a new treatment option.”
The temporary approval is subject to confirmation from the phase III trial (LAGOON) in second-line small cell lung cancer, starting in December 2021.