Luye Pharma Group’s partner PharmaMar announced that its innovative anticancer drug, Lurbinectedin, has been added to the National Comprehensive Cancer Network’s (NCCN®) Clinical Practice Guidelines in Oncology for the treatment of Small Cell Lung Cancer (SCLC). The drug was recently approved by the U.S. Food and Drug Administration (FDA) and is on license to Luye Pharma for the China market by PharmaMar.
NCCN is a not-for-profit alliance of 30 leading U.S. cancer centers. The NCCN guidelines not only serve as reference for clinical decision-making in the U.S., but are also one of the guidelines widely used in global oncology practice. The NCCN Guidelines for SCLC now include Lurbinectedin as a recommended regimen for both patients who have a relapse in six months and less after systemic therapy, and for patients who have a relapse over six months after systemic therapy. Among patients who have a relapse in six months and less, Lurbinectedin is a preferred regimen.
Just this June, the U.S. FDA approved Lurbinectedin under an accelerated approval program for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. The approval was based on the data from the open-label, single-arm monotherapy trial. Lurbinectedin is a new treatment option for patients suffering from relapsed small cell lung cancer, a type of disease for which no drug has been approved in the last 24 years.
Luye Pharma has been actively working with PharmaMar for the development of Lurbinectedin in China, so that Chinese patients can benefit from this innovative treatment as soon as possible. In April 2019, Luye Pharma and PharmaMar entered into a license development and commercialization agreement with respect to Lurbinectedin. Pursuant to the terms of the agreement, Luye Pharma has exclusive rights to the development and commercialization of Lurbinectedin for SCLC and all other indications in China. In addition, Luye Pharma also holds the right to request transfer of technology for the manufacture of Lurbinectedin in China. The clinical trials application for the drug has been accepted by the Center for Drug Evaluation of China, with the trials set to begin soon.
About Lurbinectedin
Lurbinectedin is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinacidia turbinata in which a hydrogen atom has been replaced by a methoxy group. 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 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.
TOP