FDA Approves Lynparza for Advanced Ovarian Cancer
For advanced ovarian cancer associated with defective BRCA genes
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.
Lynparza is a poly ADP-ribose polymerase inhibitor that blocks enzymes that are involved in repairing damaged DNA, the FDA said. "Today's approval constitutes the first of a new class of drugs for treating ovarian cancer," Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement.
Lynparza was approved with a companion diagnostic called BRACAnalysis CDx, designed to detect genetic mutations in the BRCA genes that are associated with ovarian cancer. An estimated 10 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, dysgeusia, dyspepsia, headache, and loss of appetite. More serious adverse reactions included lung inflammation, acute myeloid leukemia, and myelodysplastic syndrome.
Lynparza is marketed by AstraZeneca and is produced by Salt Lake City-based Myriad Genetic Laboratories.