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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
FDA (1)	BRCA1 oncogenic variants	Prostate Adenocarcinoma	Enzalutamide, Talazoparib
FDA (1)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Talazoparib
FDA (1)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	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