PharmaMar’s Zepzelca® (lurbinectedin) receives commercialization approval for the treatment of relapsed small cell lung cancer in Argentina

PharmaMar (MSE:PHM) and its partner, Adium Pharma S.A, through its Argentine subsidiary Raffo, have received the conditional marketing approval for Zepzelca® (lurbinectedin) from Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. This new approval of lurbinectedin is based on data from the open-label, multicenter, single-arm, monotherapy clinical trial conducted in 105 adult patients with recurrent SCLC (including patients with platinum-sensitive and platinum-resistant disease), which the Food and Drug Administration (FDA) used to grant the accelerated approval for lurbinectedin in the United States in 2020. In March 2021, PharmaMar and Adium Pharma signed a licensing agreement for lurbinectedin in Latin America. In the region, in addition to Argentina, lurbinectedin is already available to patients in Mexico, Ecuador and Peru. After this approval, lurbinectedin is available in a total of 18 territories around the world. Lung cancer is the third most common cancer in Argentina[i]. Around 10% to 15% of people with lung cancer have small cell lung cancer, one of the most aggressive and devastating solid tumors, that spreads rapidly resulting in poor prognosis. Many people are diagnosed after it has already reached other parts of the body[ii]. [i] Estadísticas – incidencia. (2021, 23 noviembre). Argentina.gob.ar. https://www.argentina.gob.ar/salud/instituto-nacional-del-cancer/estadisticas/incidencia [ii] Lung Cancer – Small Cell: Introduction | Cancer.Net

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