Pfizer Leads Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Pfizer.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, June 6, 2018 to Tuesday, June 12, 2018.
FDA, EMA Accept Pfizer’s NDA for Breast Cancer Drug
The US Food and Drug Administration (FDA) has accepted and granted priority review designation to Pfizer’s new drug application for talazoparib, an investigational, once-daily, oral poly ADP ribose polymerase inhibitor for treating germline (inherited) BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. The European Medicines Agency (EMA) has also accepted the marketing authorization application for talazoparib.
The FDA grants priority review designation to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act goal date for a decision by the FDA is in December 2018.
Talazoparib is also being evaluated in advanced gBRCAm breast cancer and early triple-negative breast cancer as well as DNA damage repair-deficient prostate cancer and in combination with immunotherapy in various solid tumor types.