On July 19, 2023 PharmaMar (MSE:PHM) reported that its licensing partner, Immedica Pharma AB (Immedica), has received the full approval for the commercialization of Zepzelca (lurbinectedin) by the Ministry of Health of Oman for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy (Press release, PharmaMar, JUL 19, 2023, View Source [SID1234633319]).
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This new approval of lurbinectedin is based on the data from the open-label, multi-center, single-arm monotherapy 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 2020, PharmaMar and Immedica signed a strategic alliance for the exclusive distribution and commercialization of lurbinectedin in several territories, including the United Kingdom, Ireland, the Nordic countries, some Eastern European countries, the Middle East and North Africa.
About 15% of all lung cancers are Small Cell Lung Cancer (SCLC). This type of lung cancer tends to grow and spread faster than Non-Small Cell Lung Cancer. In most people with SCLC, the cancer has already spread beyond the lungs at the time it is diagnosed [1].