Pfizer's Talzenna (talazoparib) Receives FDA Approval for BRCA-Mutated- HER2-Negative LA or MBC
Shots:
- The approval is based on EMBRACA trial results assessing Talzenna (1mg) vs CT in 431 patients with BRCA-mutated HER2-negative locally advanced or metastatic breast cancer for a duration of 11.2 mos.
- EMBRACA study results: mPFS (8.6 mos. vs 5.6mos.); ORR (62.6% vs 27.7%); reduction in risk of death 46%
- Talzenna (talazoparib) is an PARP (poly ADP ribose polymerase) inhibitor indicated for the treatment of patients with deleterious or suspected deleterious germline (inherited) BRCA-mutated HER2-negative LA or mBC in adults
Ref: Pfizer | Image: Twitter
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