PharmaMar announces the approval of Zepzelca® (lurbinectedin) for the treatment of relapsed Small Cell Lung Cancer in Hong Kong

This treatment is now available to patients in 16 territories around the world, mainly in Asia and the Americas. PharmaMar (MSE:PHM) has announced today that its licensing partner, Luye Pharma Group Ltd, has received marketing approval for Zepzelca® (lurbinectedin) by the Pharmacy and Poisons Board of the Hong Kong Special Administrative Region (SAR), for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression upon or after receiving platinum-based chemotherapy. The approval of lurbinectedin in Hong Kong is based on the data of 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), which is the same that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin. Lung cancer is the most common of all cancers in Hong Kong, in terms of incidence and mortality. In 2020, 5,422 new cases were diagnosed[1], of which SCLC accounts for 13-17%[2], and a total of 3,910 people died from this pathology in that region, representing 26.4% of all cancer deaths1. Currently, lurbinectedin is under review for its New Drug Application (NDA) in mainland China and other countries around the world. Lurbinectedin is now approved in 16 territories: 9 in Asia (United Arab Emirates, Singapore, South Korea, Qatar, Israel, Oman, Taiwan, Macau and Hong Kong); 5 in the Americas (U.S.A, Canada, Ecuador, Mexico and Peru); 1 in Oceania (Australia) and 1 in Europe (Switzerland). Patients in the other European Countries currently can only benefit from lurbinectedin through compassionate use or in a clinical trial. In order to submit in Europe the dossier for approval, the LAGOON Phase III trial is being conducted. [1]Cancer Online Resource Hub – Cancers in Hong Kong – Common cancers in Hong Kong – Lung cancer. (s. f.). https://www.cancer.gov.hk/en/hong_kong_cancer/common_cancers_in_hong_kong/lung_cancer.html [2] The Working Committee of Chinese Society of Clinical Oncology Guidelines. The 2023 Chinese Society of Clinical Oncology Guidelines for Small Cell Lung Cancer. People’s Medical Publishing House. 2023.

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