PharmaMar (MSE:PHM) and Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announce that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the New Drug Application (NDA) seeking accelerated approval for lurbinectedin for the treatment of patients with Small Cell Lung Cancer (SCLC) who have progressed after prior platinum-containing therapy. The FDA has set a PDUFA target action date of August 16, 2020.
PharmaMar submitted the NDA to FDA in December 2019 based on data from the Phase II monotherapy basket trial, which included evaluation of lurbinectedin for the treatment of relapsed SCLC. A total of 105 patients from 39 centers were recruited in Europe and the United States. The trial met its primary endpoint of the Objective Response Rate (ORR) and the results were presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2019.
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.-PR Newswire