GSK Secured FDA Approval for Zejula

| By | Cancer Drugs, FDA Approved, GSK

GlaxoSmithKline (GSK) has secured expanded approval from the US Food and Drug Administration (FDA) for its Zejula (niraparib) for the late-line treatment for women with recurrent ovarian cancer.

Zejula is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor developed to treat 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.

The expanded approval was based on the QUADRA phase 2, multi-centre, open-label, single-arm clinical study.

QUADRA is claimed to be the largest clinical trial of a PARP inhibitor in women who received three or more treatments for advanced ovarian cancer. It recruited a range of patient population including women with BRCA+ platinum-sensitive, resistant and refractory disease as well as women with HRD+ platinum-sensitive disease.

Myriad myChoice companion diagnostic testwhich was used during this clinical trial, has been approved by the FDA as the companion diagnostic test to determine HRD+ status as either tBRCA and/or a genomic instability score (GIS ≥42).

Additional analyses have been carried out in various sub populations where the efficacy of Zejula was also shown for patients with tBRCA and GIS, said the company.

GSK Oncology R&D SVP 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.”

The ongoing development programme for niraparib is comprised of a Phase 3 trial as monotherapy maintenance treatment in patients with first-line ovarian cancer (PRIMA) and the Phase 3 study as a first-line triplet maintenance treatment in ovarian cancer (FIRST), as well as a Phase 2 study of niraparib combined with bevacizumab maintenance treatment in advanced ovarian cancer (OVARIO).