PharmaMar/Jazz Pharmaceuticals get NDA priority for lung cancer drug

PharmaMar submitted the NDA to FDA in December 2019 based on data from a Phase II monotherapy basket trial (NCT02454972), 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), which was 35.2%. Median duration of response was 5.3 months, while progression-free survival was 3.9 months and overall survival was 9.3 months.

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.

Lurbinectedin (PM1183), a DNA minor groove binder analogue of trabectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumour. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets. However lurbinectedin hasn't always been successful and thus must be evaluated on a case-by-case basis.