On December 17, 2019 PharmaMar (MSE:PHM) has reported that it has submitted to the FDA (Food and Drug Administration) in the United States the New Drug Application (NDA) for lurbinectedin for the treatment of patients with SCLC who have progressed after prior platinum-containing therapy, under the accelerated approval regulations (Press release, PharmaMar, DEC 17, 2019, View Source [SID1234552440]).
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This NDA 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 (ASCO) (Free ASCO Whitepaper) meeting in June this year. A total of 105 patients from 39 centers in more than 8 Western European countries in addition to the United States were recruited. The trial met its primary endpoint of the Overall Response Rate (ORR) by both investigator and IRC (Independent Review Committee) assessment.
The FDA’s accelerated approval procedure allows for the submission of an NDA for evaluation based on the results of phase II drug investigations for the treatment of serious diseases that cover an unmet medical need. Relapsed SCLC treatment has not changed substantially in more than two decades with the last new chemical entity approved by the FDA in this setting being topotecan, in 1996.
"The application for registration under accelerated approval regulations gives us the possibility that the FDA could approve lurbinectedin in the US for treatment of small cell lung cancer in 2020 and that, if approval is obtained, could begin to be marketed 2 in the second half of 2020 in the United States", explains Luis Mora, General Manager of PharmaMar’s Oncology Business Unit.
Dr. Charles Rudin, Chief of the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center and principal investigator of the NCI Small Cell Lung Cancer Consortium, said "It is great to finally see some new therapeutic options arriving for small cell lung cancer patients, who represent a major unmet medical need. I have been following the emerging clinical trial data on lurbinectedin, which suggest appealing efficacy and a tolerable safety profile. I believe many treating physicians may welcome lurbinectedin, if approved, as a new standard of care option for their patients with recurrent small cell lung cancer." We would like to extend our sincerest gratitude to the patients, their families and caregivers, as well as the dedicated medical teams who participated in our clinical trials studies and helped bring lurbinectedin to this point.