The designation is based on a recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency.
Picoplatin is currently being studied in the pivotal Phase III study of picoplatin efficacy after relapse trial in small cell lung cancer (SCLC), which is evaluating overall survival as the primary endpoint and is being conducted under a special protocol assessment agreement with the Food and Drug Administration.
Jerry McMahon, chairman and CEO of Poniard, said: “The receipt of orphan drug designation in the European Union (EU) for picoplatin for the treatment of small cell lung cancer is an important achievement and builds on our success of obtaining orphan drug designation for picoplatin in the US.”