GSK Announces U.S. Food and Drug Administration Approval of Additional Indication for Zejula (niraparib) for Late-line Treatment for Women with Recurrent Ovarian Cancer
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) 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 (HRD) 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 PARP inhibitor has been approved for use in patients beyond those with a BRCA-positive (BRCA+) mutation as monotherapy in the late-line treatment setting. Now women with late-line, HRD-positive (HRD+) disease are eligible to be treated with a PARP inhibitor.
Axel Hoos, MD, PhD, SVP Oncology R&D, GSK, 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.”
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. QUADRA is the largest clinical trial of a PARP inhibitor in women who received three or more treatments for advanced ovarian cancer. The trial enrolled a broad patient population including women with BRCA+ platinum-sensitive, resistant and refractory disease as well as women with HRD+ platinum-sensitive disease.
Clinically meaningful and durable benefit was demonstrated in the FDA-indicated patient population with an objective response rate (ORR) of 24% (95% CI, 16–34). A median duration of response (mDOR) of 8.3 months (95% CI, 6.5–not estimable) was observed.
Additional analyses were conducted in various sub populations where efficacy of Zejula was also demonstrated for patients with tBRCA and GIS; defined as deleterious or suspected deleterious somatic or germline BRCA mutation and genomic instability score (GIS ≥42) as identified with Myriad’s myChoice companion diagnostic test, respectively: