FDA Approval Sought for Lurbinectedin in Small Cell Lung Cancer

December 17, 2019 – A new drug application (NDA) has been submitted to the FDA seeking an accelerated approval for lurbinectedin for use as a second-line treatment for patients with small cell lung cancer (SCLC), according to PharmaMar, the manufacturer of the investigational agent. The company reported in a press release that the NDA is based on results from a phase II basket trial in which lurbinectedin reached an overall response rate (ORR) of 35.2% as a … (leggi tutto)