Posted by Michael Wonder on 29 Apr 2020
FDA approves Zejula (niraparib) as the only once-daily PARP inhibitor in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status
29 April 2020 - Zejula is the only oral monotherapy available as first-line maintenance treatment for women regardless of BRCA mutational status, addressing a high unmet need in ovarian cancer.
GlaxoSmithKline today announced the US FDA approved the company’s supplemental new drug application for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.
Until now, only 20% of women with ovarian cancer, those with a BRCA mutation (BRCAm), were eligible to be treated with a PARP inhibitor as monotherapy in the first-line maintenance setting.
