Pfizer Inc. said the U.S. Food and Drug Administration accepted the new drug application for its breast cancer drug talazoparib.
The U.S. regulator also granted priority review designation to the drug, which is intended to treat patients with inherited BRCA-mutated HER2-negative breast cancer that has grown outside the organ or has spread to other parts of the body.
Priority review designation is granted to drugs that may offer a significant benefit in treatment or may provide treatment for a disease which has no adequate therapy.
The FDA expects to take a decision on the application in December.
In addition, the European Medicines Agency accepted the marketing authorization application for talazoparib in the same patient population, the New York-based drug developer said.
The submissions were based on results from a phase 3 study, named EMBRACA, which compared talazoparib with chemotherapy and showed extended survival in breast cancer patients.

