WASHINGTON, D.C. – U.S. regulators have granted accelerated approval to the first in a new class of drugs for ovarian cancer, AstraZeneca PLC's Lynparza.
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The drug is for women whose ovarian cancer is associated with certain defective genes and whose cancer persists after multiple treatments.
Women with mutated BRCA genes have a higher risk of getting ovarian cancer. About 10 percent to 15 percent of ovarian cancer cases are due to those hereditary mutations.
The Food and Drug Administration also approved a companion diagnostic test from Myriad Genetics Inc. called BRACAnalysis CDx. The test is to be used to identify women most likely to benefit from the new medication.
Each year, nearly 22,000 American women are diagnosed with ovarian cancer and more than 14,000 die from it, according to National Cancer Institute estimates.