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June 11, 2018

FDA and EMA accept marketing application for Pfizer’s talazoparib

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted Pfizer’s application seeking marketing authorisation for its talazoparib drug to treat metastatic breast cancer patients having an inherited BRCA mutation.

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted Pfizer’s marketing authorisation application for its talazoparib drug to treat metastatic breast cancer patients with an inherited BRCA mutation.

The FDA also granted priority review designation for Pfizer’s new drug application (NDA) for talazoparib.

Talazoparib is an investigational, oral, once-daily poly ADP ribose polymerase (PARP) inhibitor found to possess a dual mechanism of action in preclinical studies.

The drug was found to be potent and could block PARP enzyme activity as well as trap PARP on DNA damage sites.

Pfizer Global Product Development Oncology chief development officer Mace Rothenberg said: “Women with a hereditary BRCA mutation are typically diagnosed with breast cancer at a younger age than the overall breast cancer population and have limited treatment options when they develop advanced disease.

“Today’s filing acceptances are just the latest example of the success of Pfizer’s precision medicine approach to drug development, in this case targeting the faulty DNA damage repair process associated with BRCA mutations.”

“Today’s filing acceptances are just the latest example of the success of Pfizer’s precision medicine approach to drug development.”

The company’s NDA submission includes data from the randomised EMBRACA trial designed to compare talazoparib with chemotherapy in 431 women suffering from germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer.

Data revealed that the trial met its primary endpoint of superior progression-free survival with talazoparib that was consistent across pre-specified subgroups.

Currently, the drug is being studied for the treatment of advanced gBRCAm breast cancer, early triple negative breast cancer and DNA damage repair (DDR)-deficient prostate cancer.

It is also being investigated in conjunction with immunotherapy for different types of solid tumours.

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