New Cancer Rx Gets FDA Nod Leave a comment


(RxWiki News) The US Food and Drug Administration (FDA) has approved a medication for the maintenance treatment of adults with several types of cancer.

The medication is called Zejula (niraparib). It was approved for use in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are experiencing complete or partial response to platinum-based chemotherapy.

The FDA approved Zejula based on the results of a trial of more than 550 patients with the above types of cancer. The trial found that, compared to those who received a placebo, patients who received this medication saw an improvement in survival without their cancer progressing.

Some patients experienced side effects from niraparib. These included potentially serious high blood pressure, anemia, leukopenia, constipation, nausea, sores and ulcerations in the mouth and digestive tract, headache, fatigue, dizziness and others.

Zejula is to be taken once a day with or without food.

Tesaro markets Zejula.


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