The China National Medical Products Administration approved the New Drug Application for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase inhibitor as maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.
