AstraZeneca's ovarian cancer drug gets U.S. approval
AstraZeneca Plc's ovarian cancer drug has been granted an accelerated approval by the U.S. health regulator, a day after the treatment was approved by the European Commission.
An advisory panel to the U.S. Food and Drug Administration had voted in June against granting an accelerated approval to the drug, Lynparza, citing inadequate data.
The FDA was earlier scheduled to review the drug on Jan. 3.
Lynparza aims to treat ovarian cancer in patients with certain hereditary gene mutations. The drug is also being tested as a treatment for other cancers, including breast and gastric tumors. (1.usa.gov/1sGvFTe)
AstraZeneca expects potential sales of around $2 billion a year from the drug.
Roche AG's Avastin was approved by the FDA in November for treating patients with recurrent ovarian cancer.
Amgen Inc is also testing an ovarian cancer drug, AMG-386, in late-stage trials.
London-based AstraZeneca's U.S.-listed shares were down about 1 percent at $71.41 in afternoon trading on the New York Stock Exchange.