TUESDAY, March 28, 2017 (HealthDay News) -- Zejula (niraparib) has been approved by the U.S. Food and Drug Administration to treat adult women with recurring cancers of the ovaries, fallopian tubes or abdominal wall (peritoneum) whose tumors have shrunk in response to platinum-based chemotherapy.
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Citing the National Cancer Institute, the FDA said in a news release that more than 22,000 women are expected to be diagnosed with these cancers this year, and more than 14,000 will die of these diseases.
The drug was evaluated in clinical studies involving 553 people with any of these recurring cancers who had had their tumors shrunk by at least two doses of platinum-based chemotherapy. The average progression-free survival of certain women given Zejula was 21 months, compared with 5.5 months among women who took a placebo, the FDA said.
More serious adverse reactions could include high blood pressure and bone marrow problems, the FDA said.
Approval of Zejula was granted to Tesaro Inc.
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