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

Article

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.

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.

Related Videos
A panel of 4 experts on breast cancer
A panel of 4 experts on breast cancer
cancer pain management | Image Credits: © Burlingham - stock.adobe.com
A panel of 4 experts
A panel of 4 experts
multiple myeloma clinical trial daratumumab/ Image Credits: © Dragana Gordic - stock.adobe.com
multiple myeloma clinical trial/Image Credits: © Studio Romantic - stock.adobe.com
3d rendered illustration of lung cancer 3D illustration - Image credit:  appledesign | stock.adobe.com
A panel of 4 experts
© 2024 MJH Life Sciences

All rights reserved.