US FDA accepts GSK’s sNDA for Zejula for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer

GlaxoSmithKline plc announced that the US Food and Drug Administration (FDA) accepted the company’s submission of a supplemental New Drug Application (sNDA) seeking approval of Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. The FDA is reviewing the sNDA under the Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

The application is supported by data from the PRIMA study (ENGOT-OV26/GOG-3012), which demonstrated clinically-meaningful outcomes of niraparib treatment in the first-line maintenance setting. Results from the PRIMA study were presented at the 2019 European Society for Medical Oncology Congress and simultaneously published in the New England Journal of Medicine. The PRIMA study enrolled women who responded to first-line treatment with platinum-based chemotherapy, including those at higher risk of disease progression, a population previously under-represented in first-line ovarian cancer studies.

In the US, ovarian cancer impacts nearly 222,000 women annually, and approximately 85% of women with advanced ovarian cancer will see their disease return. With each recurrence, the time a woman may spend without her cancer progressing until the next recurrence gets shorter.

Zejula is currently approved in the US as a maintenance treatment for women with recurrent ovarian cancer who are in response to platinum-based chemotherapy regardless of BRCA mutation status. It is also approved as a treatment for women with advanced ovarian cancer, following three or more chemotherapy regimens.

PRIMA is a double-blind, randomised phase III study designed to evaluate niraparib versus placebo in women being treated first-line for Stage III or IV ovarian cancer. The study assessed the efficacy of niraparib as maintenance therapy, as measured by progression free survival. Patients in complete or partial response to first-line platinum-based chemotherapy were randomised 2:1 to niraparib or placebo.

Approximately 22,000 women are diagnosed each year with ovarian cancer in the US Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the first-line, approximately 85% of patients will experience disease recurrence. Once the disease recurs, it is rarely curable with decreasing time intervals to each subsequent recurrence.

Zejula (Niraparib) is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies, including a phase III study as a first-line triplet maintenance treatment in ovarian cancer (FIRST). There is also a phase II study of niraparib combined with bevacizumab maintenance treatment in advanced ovarian cancer (OVARIO); a phase II study of niraparib plus dostarlimab in patients with platinum resistant ovarian cancer (MOONSTONE); and a separate study with niraparib in combination with pembrolizumab in patients with triple-negative breast cancer or ovarian cancer (TOPACIO).


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