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02-19 2020

U.S. FDA Grants Priority Review of New Drug Application for Lurbinectedin (Zepsyre®) in Relapsed Small Cell Lung Cancer Luye Pharma Working with PharmaMar to Develop the Drug in China

Author:Luye Life Sciences

PharmaMar, one of Luye Pharma’s collaborative partners, has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review the New Drug Application (NDA) seeking accelerated approval for lurbinectedin for the treatment of patients with Small Cell Lung Cancer (SCLC) who have progressed after prior platinum-containing therapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 16, 2020. Luye Pharma is working together with PharmaMar to develop the drug in China. 

Lurbinectedin (Zepsyre®) is a novel ecteinascidin derivative developed by PharmaMar, a Spanish biopharmaceutical company. Luye Pharma holds the exclusive rights to develop and commercialize Lurbinectedin (Zepsyre®) in China for SCLC, Malignant Pleural Mesothelioma and all other indications, as well as the rights to the manufacturing technology for production of Lurbinectedin (Zepsyre®) in China.

PharmaMar submitted the NDA under the FDA Accelerated Approval Program in December 2019 based on data from the Phase II monotherapy basket trial, which included evaluation of Lurbinectedin (Zepsyre®) 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.

The FDA’s accelerated approval pathway allows for the submission of an NDA based on the results of Phase II drug investigations for the treatment of serious diseases that address an unmet medical need. 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.



About Lurbinectedin (Zepsyre®)
Lurbinectedin (Zepsyre®) is a synthetic compound currently under clinical investigation. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, Lurbinectedin (Zepsyre®) inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.


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