Banner_Prostate Cancer News

Pfizer’s TALZENNA® in Combination with XTANDI® Receives U.S. FDA Approval

NEW YORK, June 21, 2023–(BUSINESS WIRE)– Pfizer (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved TALZENNA (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). 

Pill spill out of glass

This approval is based on the statistically significant and clinically meaningful radiographic progression-free survival (rPFS) data from the Phase 3 TALAPRO-2 trial, which demonstrated a 55% reduction in the risk of disease progression or death in patients with mCRPC with prospectively identified HRR gene mutations (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C) treated with TALZENNA plus XTANDI vs placebo plus XTANDI (HR 0.45; 95% CI, 0.33–0.61; p<0.0001).

Metastatic CRPC is a form of prostate cancer that has spread beyond the prostate gland and has progressed despite medical or surgical treatment to lower testosterone. Approximately 10-20% of patients with prostate cancer develop mCRPC within 5-7 years of diagnosis,1 and in the U.S. in 2020, approximately 60-90 thousand of the three million cases of prostate cancer were mCRPC.2 HRR gene mutations are found in approximately 25% of tumors from men with mCRPC and have been associated with aggressive disease and poor prognosis.3,4,5,6

Read the full press release here