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The new treatment achieved primary endpoint of overall response rate (ORR) by investigator review and by the independent review committee (IRC) assessment.
PharmaMar, a Spain-based company focused on oncology, announced that its proposal to file for accelerated approval for its new drug application (NDA) for lurbinectedin monotherapy for the treatment of second-line small cell lung cancer (SCLC) was accepted by FDA. The NDA filing is anticipated for the fourth quarter of 2019.
According to an Aug. 19, 2019 press release, the approval program pushes the submission of the registration dossier for evaluation based on investigational drug results of a Phase II study for serious conditions that satisfy an unmet medical need.
The application stems from data from the SCLC cohort of the lurbinectedin Phase II monotherapy basket trial which received primary endpoint of overall response rate (ORR) with secondary endpoints including, duration of response, progression-free survival, overall survival, and safety. The trial consisted of 105 patients at 39 centers in more than nine countries in Western Europe and the United States.