GSK’s Niraparib Receives FDA Priority Review for Late-Stage Ovarian Cancer Treatment

Compiled by Violet

On June 24, GlaxoSmithKline (GSK) announced that the U.S. FDA had accepted its supplemental New Drug Application (sNDA) for the oral PARP inhibitor Zejula (niraparib) and would conduct a priority review, with a PDUFA date of October 24, 2019.

This sNDA approval authorizes Niraparib for the treatment of patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. These patients must have previously received at least three prior chemotherapy regimens and must harbor BRCA mutations or exhibit homologous recombination deficiency (HRD). For patients with HRD-positive cancer, disease progression must have occurred at least six months after the last chemotherapy treatment.

This sNDA submission is based on data from the Phase 2 QUADRA study, which was previously published in The Lancet Oncology. QUADRA was a single-arm, open-label trial evaluating the safety and activity of niraparib in patients with recurrent, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients received oral niraparib 300 mg once daily continuously until disease progression. Efficacy analysis showed that 13 out of 47 patients (28%) achieved an overall response, with a median progression-free survival of 5.5 months and a median duration of response of 9.2 months.

If approved, niraparib would become the only PARP inhibitor indicated for this specific indication. This class of drugs includes AstraZeneca and Merck’s Lynparza, as well as Clovis Oncology’s Rubraca. Although Lynparza and Rubraca are also approved for BRCA-positive patients who have undergone multiple lines of chemotherapy, they are not indicated for patients with homologous recombination deficiency (HRD).

In addition to the aforementioned three drugs, Pfizer’s PARP inhibitor Talzenna also received FDA approval last year for the treatment of patients with HER2-negative locally advanced or metastatic breast cancer harboring germline BRCA mutations.

A few years ago, as part of a large-scale asset swap with Novartis, GSK exited its oncology business. However, after Emma Walmsley became CEO in 2017, she comprehensively reformed the company’s R&D and launched a strategy that included renewed focus on oncology. In December 2018, GSK acquired Tesaro for $5.1 billion to strengthen its cancer treatment portfolio.

References:

1.GSK wins speedy FDA Zejula review in ovarian cancer niche

2.U.S. Food and Drug Administration accepts GSK’s application for ZEJULA (niraparib) in late stage ovarian cancer with priority review

3.Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial