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Ref Type
PMID
Authors
Title Talzenna (talazoparib) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211651
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Talazoparib Talazoparib 32 35
Drug Name Trade Name Synonyms Drug Classes Drug Description
Talazoparib Talzenna BMN673 PARP Inhibitor (Pan) 29 Talzenna (talazoparib) is an inhibitor of PARP1 and PARP2, which prevents the DNA repair of single strand DNA breaks, thus causing the accumulation of DNA strand breaks, genomic instability and apoptosis, and leads to lethality in homologous recombination repair deficient cells (PMID: 28242752). Talzenna (talazoparib) is FDA approved for use in patients with ERBB2 (HER2)-negative breast cancer harboring deleterious or suspected deleterious germline BRCA mutations, and in combination with Xtandi (enzalutamide) in patients with homologous recombination repair gene (ATM, ATR, BRCA1/2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C)-mutated metastatic castration-resistant prostate cancer (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ATR inact mut prostate cancer sensitive Enzalutamide + Talazoparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (TALAPRO-3) that supported FDA approval, Talzenna (talazoparib) plus Xtandi (enzalutamide) improved median progression-free survival compared to placebo (77% vs 56%, HR 0.48, p<0.001) in metastatic androgen pathway modulation-sensitive or -naive prostate cancer patients harboring alterations in homologous recombination repair genes as detected by approved assays, including ATR rearrangement, copy number loss, nonsense, frameshift, or splice site variants (PMID: 42223064; NCT04821622). 42223064 detail... detail...
RAD51C inact mut prostate cancer sensitive Enzalutamide + Talazoparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (TALAPRO-3) that supported FDA approval, Talzenna (talazoparib) and Xtandi (enzalutamide) improved median progression-free survival compared to placebo (77% vs 56%, HR 0.48, p<0.001) in metastatic androgen pathway modulation-sensitive or -naive prostate cancer patients harboring alterations in homologous recombination repair genes as detected by approved assays, including RAD51C rearrangement, copy number loss, nonsense, frameshift, or splice site variants (PMID: 42223064; NCT04821622). 42223064 detail... detail...
RAD51C inact mut prostate cancer sensitive Enzalutamide + Talazoparib FDA approved Actionable In a Phase III trial (TALAPRO-2) that supported FDA approval, Talzenna (talazoparib) plus Xtandi (enzalutamide) improved median radiographic progression-free survival compared to enzalutamide plus placebo (27.9 vs 16.4 mo, HR 0.46, p=0.0003) in patients with metastatic castration-resistant prostate cancer harboring deficient homologous recombination repair genes including RAD51C, HR was 0.66 (p=0.12) in patients with non-BRCA mutations treated with Talzenna (talazoparib) (PMID: 37285865; NCT03395197). 37285865 detail...
MLH1 inact mut prostate cancer sensitive Enzalutamide + Talazoparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (TALAPRO-3) that supported FDA approval, Talzenna (talazoparib) plus Xtandi (enzalutamide) improved median progression-free survival compared to placebo (77% vs 56%, HR 0.48, p<0.001) in metastatic androgen pathway modulation-sensitive or -naive prostate cancer patients harboring alterations in homologous recombination repair genes as detected by approved assays, including MLH1 rearrangement, copy number loss, nonsense, frameshift, or splice site variants (PMID: 42223064; NCT04821622). 42223064 detail... detail...
ATM inact mut prostate cancer sensitive Enzalutamide + Talazoparib FDA approved Actionable In a Phase III trial (TALAPRO-2) that supported FDA approval, Talzenna (talazoparib) plus Xtandi (enzalutamide) improved median radiographic progression-free survival compared to enzalutamide plus placebo (27.9 vs 16.4 mo, HR 0.46, p=0.0003) in patients with metastatic castration-resistant prostate cancer harboring deficient homologous recombination repair genes including ATM, with an HR of 0.66 (p=0.12) in patients with non-BRCA mutations treated with Talzenna (talazoparib) (PMID: 37285865; NCT03395197). detail... 37285865
MLH1 inact mut prostate cancer sensitive Enzalutamide + Talazoparib FDA approved Actionable In a Phase III trial (TALAPRO-2) that supported FDA approval, Talzenna (talazoparib) plus Xtandi (enzalutamide) improved median radiographic progression-free survival compared to enzalutamide plus placebo (27.9 vs 16.4 mo, HR 0.46, p=0.0003) in patients with metastatic castration-resistant prostate cancer harboring deficient homologous recombination repair genes including MLH1, with an HR of 0.66 (p=0.12) in patients with non-BRCA mutations treated with Talzenna (talazoparib) (PMID: 37285865; NCT03395197). 37285865 detail...
CHEK2 inact mut prostate cancer sensitive Enzalutamide + Talazoparib FDA approved Actionable In a Phase III trial (TALAPRO-2) that supported FDA approval, Talzenna (talazoparib) plus Xtandi (enzalutamide) improved median radiographic progression-free survival compared to enzalutamide plus placebo (27.9 vs 16.4 mo, HR 0.46, p=0.0003) in patients with metastatic castration-resistant prostate cancer harboring deficient homologous recombination repair genes including CHEK2, with an HR of 0.66 (p=0.12) in patients with non-BRCA mutations treated with Talzenna (talazoparib) (PMID: 37285865; NCT03395197). detail... 37285865
ATR inact mut prostate cancer sensitive Enzalutamide + Talazoparib FDA approved Actionable In a Phase III trial (TALAPRO-2) that supported FDA approval, Talzenna (talazoparib) plus Xtandi (enzalutamide) improved median radiographic progression-free survival compared to enzalutamide plus placebo (27.9 vs 16.4 mo, HR 0.46, p=0.0003) in patients with metastatic castration-resistant prostate cancer harboring deficient homologous recombination repair genes including ATR, with an HR of 0.66 (p=0.12) in patients with non-BRCA mutations treated with Talzenna (talazoparib) (PMID: 37285865; NCT03395197). detail... 37285865
CHEK2 inact mut prostate cancer sensitive Enzalutamide + Talazoparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (TALAPRO-3) that supported FDA approval, Talzenna (talazoparib) plus Xtandi (enzalutamide) improved median progression-free survival compared to placebo (77% vs 56%, HR 0.48, p<0.001) in metastatic androgen pathway modulation-sensitive or -naive prostate cancer patients harboring alterations in homologous recombination repair genes as detected by approved assays, including CHEK2 rearrangement, copy number loss, nonsense, frameshift, or splice site variants (PMID: 42223064; NCT04821622). 42223064 detail... detail...
ATM inact mut prostate cancer sensitive Enzalutamide + Talazoparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (TALAPRO-3) that supported FDA approval, Talzenna (talazoparib) plus Xtandi (enzalutamide) improved median progression-free survival compared to placebo (77% vs 56%, HR 0.48, p<0.001) in metastatic androgen pathway modulation-sensitive or -naive prostate cancer patients harboring alterations in homologous recombination repair genes as detected by approved assays, including ATM rearrangement, copy number loss, nonsense, frameshift, or splice site variants (PMID: 42223064; NCT04821622). detail... detail... 42223064