AstraZeneca PLC and Merck & Co. Inc.'s Lynparza was granted priority review in the U.S. as initial maintenance therapy for patients with advanced ovarian cancer.
The U.S. Food and Drug Administration is expected to make a decision on the companies' medicine in the second quarter of the year. If approved, Lynparza, or olaparib, will be available for patients with advanced ovarian cancer who are in complete or partial response to initial treatment with Roche Holding AG's Avastin, or bevacizumab.
As a maintenance treatment, Lynparza would be expected to bolster the effects of Avastin. Data from a phase 3 trial called Paola-1 has already demonstrated that using Lynparza as a maintenance treatment helps extend the lives of patients who have received Roche's drug.
Lynparza is already approved across multiple cancer indications around the world, including in parts of Asia, as well as in the EU. In the U.S., Lynparza is approved as maintenance therapy for women with certain types of ovarian, fallopian tube and peritoneal cancer who benefit from chemotherapy.