The European Union has approved Talzenna to treat breast cancer with the gBRCA mutation

European Commission announced approval of Pfizer's Talzenna (talazopali) for the treatment of locally advanced or metastasis breast cancer patients with hereditary BRCA mutations.PARP inhibitors have been approved for monotherapy in patients with human epithelial growth factor limes 2 negative (HER2-) local late stage (LA) or metastases breast cancer (MBC), and have previously been treated in (new) advants (unless they are not suitable for these treatments).The approval is based on the results of the EMBRACA trial - the largest Phase III study of PARP inhibitors in gBRCA mutations, HER2-LA, or MPC, which evaluated Talzenna daily compared to standard chemotherapy selected by physicians. In the trial, the drug reduced the risk of disease progressing by 46% compared to chemotherapy and more than doubled the overall response rate. For patients receiving standard chemotherapy, it also extended the average progression-free lifetime (PFS) from 5.6 months to 8.6 months.The decision is "the latest example of our successful precision medicine approach to drug development," said Andreas Penk, regional president of Pfizer's Oncology International Development Market,
an important milestone that is also "based on Pfizer's decades-long development of therapies that can improve the effectiveness of breast cancer patients." We are pleased that we are now able to offer these patients in Europe, who are often diagnosed as younger and have limited treatment options, as an effective, daily chemotherapy replacement therapy," he continued.
The approval follows the approval of the drug by the U.S. Food and Drug Administration (FDA) in October 2018. (Compiled by this web)