Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to talazoparib in combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

This is written in the approval document as:

TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

Citation

Pfizer, Inc. Talzenna (talazoparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211651s012lbl.pdf. Revised February 2024. Accessed October 30, 2024.

View API

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
FDA (1) BRCA1 oncogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) BRCA1 pathogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) BRCA2 oncogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) BRCA2 pathogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) ATM pathogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) ATM oncogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) ATR oncogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) CDK12 oncogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) ATR pathogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) FANCA oncogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) CHEK2 pathogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) CHEK2 oncogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) FANCA pathogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) MLH1 oncogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) PALB2 pathogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) PALB2 oncogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) MLH1 pathogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) MRE11 oncogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) RAD51C pathogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) RAD51C oncogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) MRE11 pathogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) NBN oncogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) NBN pathogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib
FDA (1) CDK12 pathogenic variants Prostate Adenocarcinoma Enzalutamide, Talazoparib