PARP Inhibitor Ovarian Cancer Indications Withdrawn

Federal Register notice: FDA is announcing that it is withdrawing approval of the indications for treating adult patients with advanced ovarian cancer for poly (ADP-ribose) polymerase (PARP) inhibitors under three NDAs — Clovis Oncology’s Rubraca (rucaparib), AstraZeneca’s Lynparza (olaparib), and GlaxoSmithKline’s Zejula (niraparib). The agency had earlier requested that the individual indication be withdrawn because data from randomized trials of rucaparib and olaparib in similar treatment settings showed overall survival may be reduced in patients receiving PARP inhibitors. FDA stated that these results from two independent trials were concerning and suggested a class-wide effect for PARP inhibitors. The three sponsors have each voluntarily requested that the agency withdraw approval of the indications in response to FDA’s request. To view the notice, click here.