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PharmaMar/Jazz Pharmaceuticals get NDA priority for lung cancer drug

17.02.2020
by tg

PharmaMar and Jazz Pharmaceuticals have received FDA Priority Review of a NDA for lurbinectedin in relapsed SCLC (Small Cell Lung Cancer).

The PDUFA date was set for August 16, 2020 by the US Food and Drug Administration (FDA) for lurbinectedin as second-line treatment for patients with SCLC who relapsed following platium-based chemotherapy. The synthetic drug developed by PharmaMar SA (Madrid, Spain) and exclusively licenced by Jazz Pharmaceuticals plc (Dublin, Ireland) in December 2019 works by blocking RNA Polymerase II dependent oncogenic transcription programmes and modulating activity of tumour-associated macrophages.

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.

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