The European Commission has announced the approval of Pfizer’s Talzenna (talazoparib) for patients with inherited BRCA-mutated locally advanced or metatastatic breast cancer.
The PARP inhibitor has been approved as monotherapy for patients who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC), and have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant (unless they are not suitable for these treatments).
The approval is based on results from the EMBRACA trial - the largest Phase III study of a PARP inhibitor in gBRCA-mutated, HER2- LA or MBC, which evaluated once-daily Talzenna compared to physician’s choice standard chemotherapy. In the trial the drug reduced the risk of disease progression by 46% and more than doubled the overall response rate compared to chemotherapy. It also extended median progression free survival to 8.6 months from 5.6 months for those treated with standard chemotherapy.
The decision is “the latest example of our successful precision medicine approach to drug development,” said Andreas Penk, regional president, Oncology International Developed Markets at Pfizer.
The important milestone also “builds on Pfizer’s decades-long legacy of developing therapies that improve outcomes for patients with breast cancer. We are thrilled that we can now offer these patients in Europe, who are often diagnosed at a younger age and have limited treatment options, an effective, once-daily, alternative treatment to chemotherapy,” he continued.
The approval follows the medicine’s approval by the US Food and Drug Administration (FDA) in October 2018.