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FDA approves GSK’s sNDA application for Zejula (niraparib)

GlaxoSmithKline plc recently announced that the U.S. Food and Drug Administration (FDA) acknowledged the organization’s accommodation of a supplemental New Drug Application (sNDA) looking for endorsement of Zejula (niraparib).  The drug will be used as a support treatment in the principal line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy.

Ovarian cancer begins in the ovaries with abnormal growth of the ovarian cells. If left untreated, the tumor can spread to other parts of the body as well. Ovaries are two female reproductive glands that produce the ova or egg, along with producing hormones estrogen and progesterone.

The symptoms of the cancer resemble common illnesses, leading them to be neglected by the patients. The early symptoms include abdominal bloating, pressure, pain, increased urination and difficulty in eating.

The FDA is investigating the sNDA under the Real-Time Oncology Review (RTOR) experimental program, which means to investigate a progressively productive procedure to guarantee that ‘safe and effective’ medicines and drug treatments are accessible to patients as soon as possible.

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The application is bolstered by information from the PRIMA study (ENGOT-OV26/GOG-3012), which exhibited clinically significant results of niraparib treatment in the first line support setting. Published in the New England Journal of Medicine and presented at the 2019 European Society for Medical Oncology Congress, the PRIMA study selected women who reacted 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 growth effects almost 222,000 women annually and roughly 85% of them will see their cancer return. “With every recurrence, the time a woman may spend without her cancer progressing until the next recurrence gets shorter.”

Zejula is presently endorsed in the U.S. as a support treatment for women with repetitive ovarian cancer growth who are in light of platinum-based chemotherapy, regardless of ‘BRCA mutation status’. It is likewise affirmed as a treatment for women with progressed ovarian growth, following at least three chemotherapy regimens.


PRIMA is a randomized Phase III investigation intended to assess ‘niraparib versus placebo’ treatment in women being given the first-line for Stage III or IV ovarian disease. The investigation evaluated the adequacy of niraparib as support treatment, as estimated by “progression free survival”. “Patients in complete or partial response to first-line platinum-based chemotherapy were randomized 2:1 to niraparib or placebo.”

About Zejula (noraparib)

Niraparib is an oral, once-every day PARP inhibitor that is right now being assessed in various crucial preliminaries. GSK is developing a vigorous “niraparib clinical development program by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics.”

Currently there are several studies being considered in the development program, “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).”


Mariyam Tanveer

Recently graduated from LUMS, I now work as Researcher and a Freelance Writer on Ask Health News

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