Posted by Michael Wonder on 18 Dec 2019
PharmaMar has filed new drug application for lurbinectedin with the FDA for the treatment of relapsed small cell lung cancer
17 December 2019 - The application is based on the phase II multicenter basket trial data.
PharmaMar has announced that it has submitted to the FDA in the United States the new drug application for lurbinectedin for the treatment of patients with SCLC who have progressed after prior platinum-containing therapy, under the accelerated approval regulations.
This application is based on data from the phase II monotherapy basket trial with lurbinectedin for the treatment of SCLC, the results of which were presented at the American Society of Clinical Oncology meeting in June this year.
