Zejula® (niraparib) – Indication removal
September 14, 2022 - The FDA approved an indication removal for GlaxoSmithKline’s Zejula (niraparib), for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 3 or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency positive status defined by either: a deleterious or suspected deleterious BRCA mutation, or genomic instability and who have progressed more than 6 months after response to the last platinum-based chemotherapy.
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