FDA Accepts GSK's Supplemental New Drug Application for Niraparib as First-Line Maintenance Therapy in Advanced Ovarian Cancer Regardless of Biomarker Status

On the 25th, GlaxoSmithKline (GSK) announced that the U.S. FDA has accepted the company’s supplemental new drug application (sNDA) for the PARP inhibitor niraparib (brand name Zejula). This application seeks approval for using niraparib as maintenance therapy in first-line treatment of patients with advanced ovarian cancer who have responded to platinum-based chemotherapy, regardless of their biomarker status. The FDA will evaluate this application under the Real-Time Oncology Review (RTOR) pilot program, which is expected to expedite the review process.

The press release noted that in the United States, ovarian cancer affects more than 220,000 women, and approximately 85% of patients with advanced-stage ovarian cancer experience disease recurrence. With each recurrence, the remission period before the next relapse becomes progressively shorter.

Niraparib is a PARP inhibitor acquired by GSK through its acquisition of TESARO. PARP inhibitors are targeted therapies that kill cancer cells by inhibiting the PARP-mediated DNA damage response (DDR). Leveraging the principle of "synthetic lethality," they selectively kill cancer cells without affecting healthy cells.

This application is based on the PRIMA clinical trial. The trial data demonstrated that niraparib, as maintenance therapy, provides clinically meaningful benefits for patients with advanced ovarian cancer. These results were presented at the 2019 ESMO Congress and published in The New England Journal of Medicine.

Trial results demonstrated that, regardless of patients’ biomarker status, Zejula reduced the risk of disease progression or death by 38% (HR=0.62; 95% CI, 0.50–0.75; p<0.001). The median progression-free survival (PFS) was 13.8 months in the Zejula group versus 8.2 months in the control group. Among these:

Risk was reduced by 60% in patients with BRCA mutations (HR=0.40, 95% CI, 0.27-0.62, p<0.001).

The risk was reduced by 50% in patients with wild-type BRCA genes but homologous recombination deficiency (HR-deficient) (HR=0.50, 95% CI, 0.30-0.83, p=0.006).

Patients with normal homologous recombination had a 32% reduced risk (HR=0.68, 95% CI, 0.49-0.94, p=0.020).

In China, niraparib, developed by Zai Lab, was also approved for marketing by the National Medical Products Administration at the end of last year as maintenance therapy for adult patients with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved a complete or partial response to platinum-based chemotherapy.

We look forward to the early completion of the review of this innovative therapy, bringing benefit to more ovarian cancer patients.

References:

[1] U.S. FDA accepts GSK’s sNDA application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer. Retrieved February 24, 2020, from https://www.gsk.com/en-gb/media/press-releases/us-fda-accepts-gsk-s-snda-application-for-zejula-niraparib-for-first-line-maintenance-treatment-for-women-with-platinum-responsive-advanced-ovarian-cancer/

Original Title: Express | FDA Accepts Supplemental New Drug Application for Niraparib as First-Line Maintenance Therapy in Ovarian Cancer Patients

▽Follow [WuXi AppTecGermany】WeChat Official Account