Biopharmaceutical company PharmaMar (MSE:PHM) and Jazz Pharmaceuticals plc (Nasdaq:JAZZ) jointly announced on Monday that a New Drug Application (NDA) has been accepted under the US Food and Drug Administration (FDA) Priority Review.

The companies are seeking accelerated approval for lurbinectedin to treat patients with Small Cell Lung Cancer (SCLC) who have progressed after prior platinum-containing therapy.

The US FDA has reportedly set a PDUFA target action date of 16 August 2020.

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

This US FDA submission is based on data from the partnership's Phase II monotherapy basket trial, which included evaluation of lurbinectedin for the treatment of relapsed SCLC.

A total of 105 patients from 39 centres were recruited in Europe and the US. The Phase II trial met its primary endpoint of the Objective Response Rate (ORR), concluded the companies.