FDA Approves Talzenna to Treat BRCA-mutated Metastatic Breast Cancer

FDA Approves Talzenna to Treat BRCA-mutated Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) has approved Pfizer’s Talzenna (talazoparib) for the treatment of HER2-negative advanced breast cancer in adult patients with inherited BRCA mutations. The FDA also stated that patients’ eligibility for the treatment with Talzenna must be evaluated using Myriad Genetics’ BRACAnalysis CDx test, which was also approved by the agency. The FDA’s approvals were based on results from the ongoing EMBRACA Phase 3 trial (NCT01945775), which evaluated the safety and effectiveness of 1 mg of Talzenna — compared to physician’s choice of chemotherapy including capecitibine, eribulin, gemcitabine, or vinorelbine — in patients with inherited BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. The study enrolled 431 patients who previously had been treated with an anthracycline (like doxorubicin) and/or a taxane (such as such as paclitaxel and docetaxel) and no more than three previous chemotherapy regimens for locally advanced or metastatic cancer. The trial met its primary goal, with Talzenna-treated patients living significantly longer without their disease progressing (8.6 months) than those given standard chemotherapy (5.6 months). These results highlighted a 46% reduction in the risk of cancer progression or death with Talzenna use. This benefit was consistent across several patient subgroups, including women with triple-negative (a tumor not producing estrogen, progesterone, or HER2 receptors) or hormone receptor-positive breast cancer, patients with a history of brain metastases, and patients previously treated or untreated with chemotherapy. Talzenna was also found to significantly delay clinically meaningful deterioration in patients’ global health or quality of life, c
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