Posted by Michael Wonder on 24 Oct 2019
GSK announces U.S. FDA approval of additional indication for Zejula (niraparib) for late-line treatment for women with recurrent ovarian cancer
23 October 2019 - Expanded indication allows for treatment of women whose advanced ovarian cancer is associated with homologous recombination deficiency.
GlaxoSmithKline today announced that the company has received approval from the U.S. FDA for an expanded indication for Zejula (niraparib), an oral, once-daily poly polymerase inhibitor for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients, who have been treated with three 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 six months after response to the last platinum-based chemotherapy.
Patient selection is based on an FDA approved companion diagnostic for Zejula.
This new indication is based on the QUADRA study, a Phase 2, multi-center, open label, single arm clinical study representing a real world, difficult-to-treat patient population with high unmet needs.
