PharmaMar (MSE: PHM) today announced that it has received Temporary Marketing Approval for Zepzelca (lurbinectedin) from the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of adult patients with metastatic small cell lung cancer with progression of disease during 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 in 105 adult patients with recurrent metastatic small cell lung cancer (including patients with platinum-sensitive, platinum-resistant, and refractory disease). to platinum), which the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the United States.

Temporary authorization is granted under certain conditions defined by law in order to make drugs available to patients as soon as possible for the treatment of life-threatening diseases with limited therapeutic options.

Luis Mora, General Director 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 Switzerland, 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.

Contact:

Tel: +34 91 846 6000

Email: pharmamar@pharmamar.com

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