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PharmaMar/Jazz Pharmaceuticals get NDA priority for lung cancer drug

February 17, 2020 / European Biotechnology
SHARESHARESHARE

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.