U.S. FDA accepts GSK's sNDA application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer

-  Submission based on data from the Phase III PRIMA clinical study that demonstrated clinically-meaningful outcomes of niraparib maintenance treatment in the first-line setting regardless of biomarker status

-  The application is being reviewed under the FDA's Real-Time Oncology Review pilot program

LONDON, UK I February 24, 2020 I GlaxoSmithKline plc today announced that the U.S. 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.i 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 U.S., ovarian cancer impacts nearly 222,000 women annually,ii and approximately 85% of women with advanced ovarian cancer will see their disease return.iii 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 U.S. 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.

About Ovarian Cancer
Approximately 22,000 women are diagnosed each year with ovarian cancer in the U.S. Ovarian cancer is the fifth most frequent cause of cancer death among women.iv 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.

About Zejula (niraparib)
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).


ZEJULA is indicated:

  • for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
  • for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer 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.

Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA.

GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK's pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

About GSK 
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

i González-Martín A, Pothuri B, Vergote I, Christensen R, et al. Niraparib in patients with newly diagnosed advanced ovarian cancer. New England Journal of Medicine. 2019. doi:10.1056/NEJMoa1910962
ii SEER Cancer Stat Facts: Ovarian Cancer. National Cancer Institute. Bethesda, MD. http://seer.cancer.gov/statfacts/html/ovary.html. Accessed October 10, 2018.
iii Lorusso D, Mancini M, Di Rocco R, Fontanelli R, Raspagliesi F. The role of secondary surgery in recurrent ovarian cancer [published online August 5, 2012]. Int J Surg Oncol. 2012. doi:10.1155/2012/613980
iv American Cancer Society "Key Statistics for Ovarian Cancer." https://www.cancer.org/cancer/ovarian-cancer/about/key-statistics.html

SOURCE: GlaxoSmithKline

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