A European Medicines Agency (EMA) panel recommended the approval of Massachusetts-based Tesaro’s niraparib, for the treatment of recurrent ovarian cancer.
The drug, marketed as Zejula, was approved in the United States in March.
The panel’s opinion will be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. If approved, Zejula will be the first oral, once-daily poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor approved in Europe for use in patients regardless of BRCA mutation or biomarker status.
Read the Reuters coverage