Policy & Regulation
US FDA agrees to PharmaMar's proposal to file for accelerated approval of New Drug Application for lurbinectedin in monotherapy
20 August 2019 -

The US Food and Drug Administration (FFDA) has agreed with Madrid-based PharmaMar's (MSE: PHM) proposal to file for accelerated approval of its New Drug Application for lurbinectedin in monotherapy intended for the treatment of second-line small cell lung cancer (SCLC), it was reported yesterday.

The FDA's accelerated approval program enables the submission of the registration dossier for assessment based on investigational drug results of a Phase II study for serious conditions that satisfy an unmet medical need.

The application will be based on data from the SCLC cohort of the lurbinectedin Phase II monotherapy basket trial that enrolled a total of 105 patients at 39 centres in over nine countries in Western Europe and the United States. The primary endpoint of Overall Response Rate (ORR), was achieved by both the investigator and the Independent Review Committee (IRC) assessment.

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