Talzenna (talazoparib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.	2
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).	24

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Talazoparib
Sensitivity (+)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Talazoparib
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