Diplomat Pharmacy will be one of the companies distributing Zejula (niraparib), a recently approved treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in the United States.
Zejula is an oral, once-daily inhibitor of the proteins poly(ADP-ribose) polymerase (PARP) 1 and 2.
It is the first of its class to receive approval by the U.S. Food and Drug Administration (FDA) as a maintenance therapy for women with these cancer types. A maintenance therapy aims to keep cancer at bay in patients who responded well to a primary cancer treatment.
Use of Zejula does not require that patients carry mutations in the BRCA gene (a known cause of ovarian cancer) or other biomarker.
“For women living with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, Zejula (niraparib) offers new hope as a promising treatment option,” Paul Urick, Diplomat’s president, said in a news release.
The approval of Zejula was supported by positive results obtained in the NOVA clinical trial (NCT01847274). This Phase 3, double-blind, placebo-controlled, international study enrolled 553 ovarian cancer patients to test the drug’s effectiveness and safety.
Results showed that treatment with Zejula significantly increased the time to disease progression compared to placebo. This benefit was shown both in patients with mutations in the BRCA gene and other genes, as well as in patients without mutations.
The median progression-free survival (PFS) for BRCA-positive patients who received Zejula was 21 months, compared to 5.5 months in the placebo group. The median PFS among patients without BRCA mutations who received Zejula was 9.3 months, vs. 3.9 months in placebo-treated patients.
The adverse side effects associated with Zejula treatment include back, muscle, or joint pain, headache, dizziness, dry mouth, fatigue, and low levels of blood cells. It may also trigger hypertension (increased blood pressure), bone marrow anomalies, acute myeloid leukemia, and low levels of blood cells in the bone marrow. Other side effects include vomiting, cough, rash, nausea, constipation, and insomnia.
According to the National Cancer Institute, more than 22,000 women will be diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer in 2017, and more than 14,000 patients will die of those cancers.
Zejula was developed by the pharmaceutical company Tesaro.
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