Research & Development
PharmaMar and Jazz Pharmaceuticals partnership files NDA for Lurbinectedin for treating relapsed SCLC
17 February 2020 -

Biopharmaceutical company PharmaMar (MSE:PHM) and Jazz Pharmaceuticals plc (Nasdaq:JAZZ) on Friday jointly announced the submission of New Drug Application (NDA) under the US Food and Drug Administration's (FDA) priority review seeking accelerated approval of lurbinectedin for the treatment of Small Cell Lung Cancer (SCLC) following prior platinum-containing therapy.

The partnership added that the US FDA has set lurbinectedin's PDUFA target action date of 16 August 2020.

According to the partnership, Lurbinectedin (PM1183) is a selective inhibitor of the oncogenic transcription programmes on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor.

A total of 105 patients from 39 centre were recruited in Europe and the US as part of the partnership's Phase II monotherapy basket trial, which included evaluation of lurbinectedin for the treatment of relapsed SCLC. 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.

Under an exclusive license agreement, PharmaMar has granted Jazz US with the commercialization rights to lurbinectedin.