FRIDAY, Dec. 19, 2014 (HealthDay News) -- Lynparza (olaparib) has been approved by the U.S. Food and Drug Administration to treat advanced ovarian cancer associated with defective BRCA genes, the agency said Friday in a news release.
Nearly 22,000 women in the United States are projected to be diagnosed this year with ovarian cancer, and more than 14,000 will die from it, the U.S. National Cancer Institute estimates.
Lynparza was approved with a companion diagnostic called BRACAnalysis CDx, designed to detect genetic mutations in the BRCA genes that are associated with cancer of the ovaries, the female reproductive glands where eggs are formed. Some 10 percent to 15 percent of ovarian cancer cases are thought to involve this genetic defect, the FDA said.
Lynparza was evaluated in a clinical study of 137 women with ovarian cancer associated with the BRCA genetic defect. The drug's most common side effects included nausea, fatigue, vomiting, diarrhea, distorted taste, indigestion, headache and loss of appetite.
More serious adverse reactions included lung inflammation, acute myeloid leukemia, and myelodysplastic syndrome -- when the bone marrow doesn't produce enough red blood cells.
Lynparza is marketed by AstraZeneca and is produced by Salt Lake City-based Myriad Genetic Laboratories.
To learn more about this approval, visit the FDA.