PharmaMar files NDA at FDA for lurbinectedin for the treatment of patients with Small Cell Lung Cancer

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. The FDA has set a PDUFA target action date of August 16, 2020. The FDA's accelerated approval pathway allowed for the submission of an NDA based on the results of Phase II drug investigations for the treatment of serious diseases that address an unmet medical need. There remains a critical unmet need for patients with relapsed SCLC, as the treatment landscape has not changed substantially in more than two decades since the last new chemical entity, topotecan, was approved. As previously announced in December 2019, PharmaMar and Jazz Pharmaceuticals have entered into an exclusive license agreement, which became effective in January 2020, granting Jazz U.S. commercialization rights to lurbinectedin.