PharmaMar submits NDA to FDA for lurbinectedin for the treatment of patients with small cell lung cancer and licenses US rights to Jazz Pharma.

PharmaMar has announced that it has submitted to the FDA in the United States the New Drug Application (NDA) for lurbinectedin for the treatment of patients with Small Cell Lung Cancer (SCLC) who have progressed after prior platinum-containing therapy, under the accelerated approval regulations.

This NDA is based on data from the phase II monotherapy basket trial with lurbinectedin for the treatment of SCLC, the results of which were presented at the American Society of Clinical Oncology (ASCO) meeting in June this year. A total of 105 patients from 39 centers in more than 8 Western European countries in addition to the United States were recruited. The trial met its primary endpoint of the Overall Response Rate (ORR) by both investigator and IRC (Independent Review Committee) assessment.

PharmaMar and Jazz Pharmaceuticals plc announced that PharmaMar and Jazz Pharmaceuticals Ireland Limited have entered into an exclusive license agreement for lurbinectedin in the United States.