FDA approves u200c Lurbinectedin for the treatment of metastatic small cell lung cancer

On June 15, 2020, PharmaMar and Jazz Pharmaceuticals jointly announced that the U.S. Food and Drug Administration (FDA) has approved lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) who have progressed after platinum-based chemotherapy. ‌Lurbinectedin received "accelerated approval" based on overall response rate (ORR) and duration of response (DoR).

“It’s great to see a new treatment available for patients with recurrent SCLC! Lurbinectedin is the first new drug approved for second-line treatment since 1996. SCLC remains a significant unmet need. Medical need. Many in the oncology community will welcome lubitidine as a new standard treatment option for patients with recurrent small cell lung cancer," said Dr. Charles Rudin, chief of the Division of Thoracic Oncology at Memorial Sloan Kettering Cancer Center and principal investigator of the National Cancer Institute's Small Cell Lung Cancer Consortium.

“We are pleased to bring a new treatment option to patients with recurrent small cell lung cancer,” said Dr. Jose Maria Fernandez, President of PharmaMar. “The U.S. FDA’s accelerated approval of lurbinectedin highlights its potential to meet the unmet needs in small cell lung cancer.”

About lurbinectedin ( Lurbinectedin)

Lurbinectedin (Zepzelca, Lurbinectedin, also known as PM1183) is an analog of the marine compound ET-736. ET-736 is isolated from ascidian (Ecteinacidiaturbinata). Lurbinectedin is structurally formed by replacing one of the hydrogen atoms with a methoxy group. It is a selective inhibitor of oncogenic transcriptional programs on which many tumors are particularly dependent. In addition to its effects on cancer cells, rupitidine inhibits oncogenic transcription in tumor-associated macrophages and downregulates the production of cytokines critical for tumor growth. Transcriptional addiction is a well-established target in these diseases, many of which lack other actionable targets.