Pfizer’s Talzenna (talazoparib) Receives European Commission Approval for Germline BRCA-Mutated Locally Advanced or Metastatic Breast Cancer

Pfizer’s Talzenna (talazoparib) Receives European Commission Approval for Germline BRCA-Mutated Locally Advanced or Metastatic Breast Cancer

Shots:

  • The approval is based on P-III EMBRACA study results assessing Talzenna (qd, 1mg) vs CT (capecitabine/eribulin/gemcitabine/vinorelbine) in 431 patients in ratio (2:1) with inherited BRCA1/2 mutation & LA or m-triple-negative or HR+/HER2- breast cancer, prior treated with 3L CT regimen
  • The P-III EMBRACA study results: mPFS (8.6 mos.vs 5.6mos.); ORR (62.6% vs 27.2%); 46% reduction in the risk of disease progression
  • Talzenna is a PARP inhibitor, being evaluated in multiple studies for breast and other cancers, including early triple-negative breast cancer and prostate cancer and has received FDA’s approval for gBRCAm HER2-, LA or m-breast cancer

Click here to read full press release/ article | Ref: Pfizer | Image: Q Costa Rica