The US Food and Drug Administration (FDA) has approved GlaxoSmithKline’s (GSK) expanded indication for Zejula (niraparib) for late-line treatment for women with recurrent ovarian cancer.

The expanded indication allows for an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients treated with three or more prior chemotherapy regimens, and whose cancer is associated with homologous recombination deficiency (HRD) positive status.

The approval represents the first time a PARP inhibitor permitted for use in patients beyond those with a BRCA-positive (BRCA+) mutation as monotherapy in the late-line treatment setting.

Women with late-line, HRD+ disease can be treated with PARP inhibitor

With the FDA approval, women with late-line, HRD-positive (HRD+) disease can be treated with a PARP inhibitor.

GSK Oncology R&D senior vice-president Axel Hoos said: “This new indication reinforces our commitment to providing treatment options for more women impacted by ovarian cancer, especially those with high unmet needs. We look forward to continuing our clinical development program of Zejula and understanding its full potential as a treatment for people living with ovarian cancer.”

GSK said that the new indication is based on the QUADRA study, a Phase 2, multi-centre, open-label, single-arm clinical study representing a difficult-to-treat patient population with high unmet needs.

Said to be a largest clinical trial of a PARP inhibitor in women who received three or more treatments for advanced ovarian cancer, QUADRA trial was conducted on patients including women with BRCA+ platinum-sensitive, resistant and refractory disease as well as women with HRD+ platinum-sensitive disease.

GSK identified clinically meaningful and durable benefit in the FDA-indicated patient population with an objective response rate (ORR) of 24% (95% CI, 16–34) while a median duration of response (mDOR) of 8.3 months (95% CI, 6.5–not estimable) was observed.

Following additional analysis on various sub populations, the efficacy of Zejula was demonstrated for patients with tBRCA and GIS

University of Oklahoma Stephenson Cancer Center gynecologic oncology section associate professor and Oklahoma TSET Phase 1 Program director Dr Kathleen Moore said: “Ovarian cancer has a high rate of recurrence, so there is a real need for therapies for women whose cancer has progressed through multiple lines of treatment and who have few or no options left.

“It’s meaningful to see that Zejula has been approved as a late-line treatment for women including those with and without BRCA mutations.”