Talazoparib, Potential Treatment for Metastatic Breast Cancer with BRCA Mutations, Up for US and EU Approval

Talazoparib, Potential Treatment for Metastatic Breast Cancer with BRCA Mutations, Up for US and  EU Approval
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have agreed to review Pfizer’s application for talazoparib, a candidate for the treatment of metastatic breast cancer in patients with inherited BRCA mutations. The request for the oral medicine's approval to the FDA was accepted with priority review status, meaning talazoparib addresses an unmet patient need. A decision is expected by December. Talazoparib is an investigational, once-daily PARP (poly ADP ribose polymerase) inhibitor, meaning it belongs to a drug class targeting DNA repair processes. The anti-cancer medicine has been shown in preclinical studies to be highly potent due to its dual mechanism of action, with potential to induce tumor cell death by blocking PARP enzyme activity and trapping PARP on sites of DNA damage. In patients with BRCA mutations, the PARP enzyme is particularly important in repairing damage to DNA. When this enzyme is prevented from doing its job, cells — particularly fast-growing cancer cells — can accumulate enough DNA damage to kill them. “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,” Mace Rothenberg, MD, chief development officer of oncology at Pfizer, said in a press release. “We are now one step closer to offering a potential alternative to chemotherapy for
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