PharmaMar receives orphan drug designation for lurbinectedin from the Swiss Agency for Therapeutic Products for malignant mesothelioma
December 28, 2022 at 08:30 am EST
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PharmaMar (PHM: MSE) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted Orphan Drug designation to lurbinectedin for the treatment of malignant mesothelioma.
This decision has been based on the recognition as an orphan drug granted by the European Medicines Agency in August 2021.
Malignant mesothelioma is a tumor arising from the mesothelial cells of the pleural, peritoneal, or pericardial lining of the lung and is often associated with asbestos exposure, usually with a very poor prognosis at diagnosis. There is currently no cure for most malignant mesotheliomas. For this reason, the objective of current cancer treatments (surgery, radiotherapy and chemotherapy) is to reduce or eliminate symptoms, as well as prolong progression-free survival (PFS) and/or overall survival (OS). It is estimated that the incidence of this type of cancer may increase in the coming years, after exposure to asbestos, since there is a long latency period after exposure before a Malignant Mesothelioma forms.
Pharma Mar SA is a Spain-based integrated biopharmaceutical company focused on oncology and committed to research and development (R&D) of antitumor drugs of marine origin. The Company, through its subsidiaries, operates three business segments: Oncology, Diagnostics and RNA interference. The Oncology segment encompasses research, develop and market anti-tumor drugs. The Diagnostics segment includes the development and marketing of diagnostic kits. The RNA interference segment consist of the development of drugs with therapeutic activity based on reducing or silencing gene expression. The Companyâs product portfolio includes Yondelis and ZEPZELCA. Yondelis (trabectedin) is indicated for the treatment of advanced soft tissue sarcoma, as well as for the treatment of relapsed platinum-sensitive ovarian cancer. ZEPZELCA (lurbinectedin) is indicated for the treatment of metastatic small cell lung cancer (SCLC) with disease progression. The Company is active globally.