PharmaMar announces the full approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer in Peru

PharmaMar (MSE:PHM) has announced today that its licensing partner, Adium Pharma, has received the full approval for commercialization for Zepzelca® (lurbinectedin) from the Ministry of Health of Peru 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 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 and platinum-resistant disease), that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the US. In March 2021, PharmaMar and Adium Pharma signed a licensing agreement for lurbinectedin in Latin America. The Peruvian approval of lurbinectedin has been preceded by the approval in Mexico and Ecuador. With this approval, lurbinectedin is now authorized in 14 countries worldwide. SCLC accounted for up to 15% of all lung cancer cases[1]. Most SCLC patients are already at the advanced stage upon diagnosis, resulting in poor prognosis. [1] Data Monitor: Small Cell Lung Cancer (SCLC) Globocan 2020. All ages, both genders.

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