FDA Approves Treatment for HER2-Negative Breast Cancer with Germline BRCA Mutation

Officials with the FDA have approved talazoparib (Talzenna, Pfizer) for the treatment of HER2-negative locally advanced or metastatic breast cancer with germline BRCA (gBRCA) mutations, according to a press release.

Talazoparib, a poly ADP-ribose polymerase (PARP) inhibitor, is indicated for patients with known deleterious or suspected deleterious gBRCA-mutated breast cancer who are selected for the therapy based on an FDA-approved companion diagnostic.

As a dual-mechanism PARP inhibitor, talazoparib both inhibits and traps the PARP enzyme, which may lead to heightened cell death, according to Pfizer.

The approval was based on clinical data from the EMBRACA trial, which included 431 participants with a known deleterious or suspected deleterious gBRCA mutation who have received no more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Additionally, patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.

Click to continue reading on Specialty Pharmacy Times.