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Innovative Anti-tumor Drug Lurbinectedin Received Clinical Approval in China
发布时间：
2020-08-28 14:18
Following the approval of the innovative anti-tumor drug Lurbinectedin in the United States in June this year, it is used to treat adult patients with metastatic Small Cell Lung Caner (SCLC) who have progressed during or after platinum drug chemotherapy. According to the latest announcement by the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration on August 27,the innovative anti-tumor drug Lurbinectedin introduced by Luye Pharma has been approved for clinical use in China and is intended to be used for the treatment of SCLC patients after the failure of first-line platinum-containing chemotherapy.
SCLC is one of the more common types of lung cancer, accounting for about 15%-20% of bronchogenic lung cancer. Although compared with other types of lung cancer, SCLC accounts for a small proportion of all lung cancers and has better curative effect of chemotherapy and radiotherapy, unfortunately, most SCLC patients will have relapse and drug resistance after initial treatment. which is often difficult to cure.
Lurbinectedin is an Ecteinascidins derivative, an inhibitor of RNA polymerase II, and can covalently bind to the minor groove on the DNA double helix structure. RNA polymerase II is often over-activated during the transcription process of tumor cells, which can make tumor cells aberrate and apoptosis during mitosis, thereby reducing cell proliferation.
This approval is mainly based on the clinical data of an open-label, multi-center, single-arm study of 105 patients with SCLC (including platinum-sensitive and resistant patients) who have progressed after platinum-based chemotherapy with Lurbinectedin monotherapy. The results of the study showed that the Overall Response Rate (ORR) assessed by the investigator reached 35%, and the median Duration of Response (DoR) was 5.3 months; the Independent Review Committee (IRC) assessed ORR reached 30%, and the median DoR was 5.1 months.
In addition to the approval of Lurbinectedin in the United States, lurbinectedin has recently passed a special access mechanism to give priority to SCLC patients in Australia and Singapore. In addition, lurbinectedin has successively obtained orphan drug qualifications for the treatment of SCLC in the United States, the European Union, Switzerland and Australia.
The approval of Lurbinectedin in China this time means that this product is about to enter the clinical development stage in China. Lurbinectedin is expected to provide new treatment options for SCLC patients and to bring more hope to SCLC patients.
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