FDA approves Zai Lab partner, GSK’s expanded indication for Zejula
Zai Lab’s partner GlaxoSmithKline has received the Food and Drug Administration’s clearance for an expanded indication for Zejula (niraparib). The oral, once-daily drug now is indicated 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 represents the first time a poly ADP ribose polymerase, or PARP, inhibitor has been approved for use in patients beyond those with a BRCA-positive mutation as monotherapy in the late-line treatment setting. Now women with late-line, HRD-positive disease are eligible to be treated with a PARP inhibitor.
Niraparib was approved in March 2017 by the FDA in the United States and in November 2017 by the EMA in the European Union under the trade name Zejula as a maintenance treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.