Zejula Approved for Certain Female Cancers
TUESDAY, March 28, 2017 -- 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.
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.
Zejula is designed to block an enzyme involved in repairing damaged DNA. The thought is that by blocking this enzyme, cancer cells would die and slow down or stop tumor growth, the FDA said.
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.
The most common side effects were low levels of red blood cells, white blood cells or blood platelets; heart palpitations, nausea, constipation, abdominal pain, and mucous membrane inflammation.
More serious adverse reactions could include high blood pressure and bone marrow problems, the FDA said.
Approval of Zejula was granted to Tesaro Inc.
Visit the FDA to learn more.
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Posted: March 2017