On March 8, 2023 PharmaMar (MSE:PHM) has reported today that it has received the Temporary Authorisation for the commercialization of Zepzelca (lurbinectedin) by the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy without central nervous system (CNS) metastases (Press release, PharmaMar, MAR 8, 2023, View Source [SID1234628316]).

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This new approval of lurbinectedin is based on the monotherapy clinical data from the open-label, multi-center, single-arm clinical trial in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive,platinum-resistant and platinum refractory disease), that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the US.

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

Luis Mora,Managing Director of the PharmaMar’s Oncology & Virology Business Units, said: "We are very pleased to announce for patients that Switzerland is the first country in Europe to approve lurbinectedin. It will be marketed directly by PharmaMar’s team. This approval brings hope for many patients with metastatic SCLC in Switzerland, who will now have a new treatment option." The temporary authorisation is subject to confirmation with the LAGOON Phase III clinical trial in 2nd line SCLC, initiated in December 2021.