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
Subscribe or to access all post and page content.

Leave a Comment

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.