The US Food and Drug Administration approved AstraZeneca's first-in-class drug Lynparza (olaparib) for treating ovarian cancer linked to specific genetic mutations. Lynparza—a poly ADP-ribose polymerase (PARP) inhibitor—was given a green light on December 19 for treating ovarian cancer in women with mutated BRCA1 and BRCA2 genes, who have already failed on three or more chemotherapy treatments. The accelerated approval is a surprise considering an earlier negative panel vote (11-2) against recommending the drug. The agency approved the drug based on the drugmaker's reanalysis of trial data in patients with defective BRCA genes. The drug also won the go-ahead from the European Commission on the previous day. AstraZeneca projects $2 billion a year sales for Lynparza, although the indication is narrow. It is also a win for Myriad Genetics, as Lynparza was approved in conjunction with the BRACAnalysis companion diagnostic test to identify patients with BRCA1/2 BRCA mutations. Under the FDA's accelerated-approval program, remaining on the market is contingent on verifying the drug's benefits in later studies.