Zejula Monotherapy Approved for Some Late-Line Gyn Cancers

Published by W Butcher on

The FDA granted approval for an expanded indication for the poly(adenosine diphosphate–ribose) polymerase inhibitor niraparib (Zejula, GlaxoSmithKline): treatment of patients with advanced ovarian, fallopian tube or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status (either with a BRCA mutation that is deleterious/suspected to be deleterious or with genomic instability in patients who have progressed more than six months after responding to their last platinum-based chemotherapy).

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