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.

Therapeutic response

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

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