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AboutAboutUnmet needs in HRRm mCRPCMOATALAPRO-2 study designBaseline patient characteristicsTreatment guidelinesHRRm Testing

HRRm Testing

Why and when to test

How to test

EfficacyEfficacyrPFS: Primary and follow-uprPFS in patient subgroupsOSORRPSASafetySafetyWarnings and precautionsAdverse reactionsDosingDosingDosing and administrationDose modificationsSoft gelatin capsuleTherapy management strategiesSupportSupportCoverage and accessPatient supportResourcesContact a rep
Prescribing Information for Soft Gelatin CapsulesPrescribing Information for Hard CapsulesIndicationPatient SiteSee Information on a Different Indication
rPFS in Patient SubgroupsrPFS in Patient Subgroups Primary analysis: Exploratory subgroup analyses of rPFS in HRRm mCRPC patients based on BRCA1/2 status1,2

in the risk of disease progression or death in BRCAm patients with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.20 [95% CI, 0.11–0.36])

  • Median rPFS was not reached with TALZENNA + XTANDI + ADT vs 11 months with XTANDI + placebo + ADT
  • 15/71 (21%) events with TALZENNA + XTANDI + ADT vs 54/84 (64%) events with XTANDI + placebo + ADT

in the risk of disease progression or death in non-BRCA HRRm patients with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.72 [95% CI, 0.49–1.07])

  • Median rPFS was 24.7 months with TALZENNA + XTANDI + ADT vs 16.7 months with XTANDI + placebo + ADT
  • 51/129 (40%) events with TALZENNA + XTANDI + ADT vs 50/115 (43%) events with XTANDI + placebo + ADT
 “Overall” and “BRCA1/2 alteration” subgroups are included in the TALZENNA USPI; all other data are not included in the TALZENNA USPI. These descriptive subgroup analyses are exploratory and not alpha protected per the statistical analysis plan. Small sample size is a limitation of subgroup analyses.*
  • Patients in the TALAPRO-2 study were stratified by prior treatment with a CYP17 inhibitor (including abiraterone)† or docetaxel (yes/no)1,2
 “Overall” and “BRCA1/2 alteration” subgroups are included in the TALZENNA USPI; all other data are not included in the TALZENNA USPI. These descriptive subgroup analyses are exploratory and not alpha protected per the statistical analysis plan. Small sample size is a limitation of subgroup analyses.*
  • Patients in the TALAPRO-2 study were stratified by prior treatment with a CYP17 inhibitor (including abiraterone)† or docetaxel (yes/no)1,2
 Follow-up analysis: Exploratory subgroup analysis of rPFS in patients with HRRm mCRPC based on BRCA1/2 status3 The information below is not included in the TALZENNA USPI. These analyses were descriptive updates to the primary rPFS analyses and not alpha protected. Small sample size is a limitation of this exploratory subgroup analysis. BRCAm: 74% reduction in the risk of disease progression or death in BRCAm patients with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.26 [95% CI, 0.16–0.42])3
  • Median rPFS was not reached and was at least 30.2 months with TALZENNA + XTANDI + ADT and was 11 months with XTANDI + placebo + ADT1,3
  • 27/71 (38.0%) events with TALZENNA + XTANDI + ADT and 56/84 (66.7%) events with XTANDI + placebo + ADT1,3
Non-BRCAm: 35% reduction in the risk of disease progression or death in non-BRCA HRRm patients with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.65 [95% CI, 0.47–0.91])3
  • Median rPFS was 24.7 months with TALZENNA + XTANDI + ADT and 16.6 months with XTANDI + placebo + ADT1,3
  • 72/129 (55.8%) events with TALZENNA + XTANDI + ADT and 71/115 (61.7%) events with XTANDI + placebo + ADT1,3

Patients in the TALAPRO-2 study were stratified by prior treatment with a CYP17 inhibitor (including abiraterone) or docetaxel (yes/no)*1,2

Primary analysis: Exploratory subgroup analyses of rPFS in HRRm patients based on BRCA1/2 status1,2

in the risk of disease progression or death in BRCAm patients with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.20 [95% CI, 0.11–0.36])

  • Median rPFS was not reached with TALZENNA + XTANDI + ADT vs 11 months with XTANDI + placebo + ADT
  • 15/71 (21%) events with TALZENNA + XTANDI + ADT vs 54/84 (64%) events with XTANDI + placebo + ADT

in the risk of disease progression or death in non-BRCAm patients with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.72 [95% CI, 0.49–1.07])

  • Median rPFS was 24.7 months with TALZENNA + XTANDI + ADT vs 16.7 months with XTANDI + placebo + ADT
  • 51/129 (40%) events with TALZENNA + XTANDI + ADT vs 50/115 (43%) events with XTANDI + placebo + ADT
Follow-up analysis: Prespecified subgroup analysis of rPFS in patients with HRRm based on BRCA1/2 status3

The information below is not included in the TALZENNA USPI. This prespecified analysis was a descriptive update to the primary rPFS analysis. Sample size is a limitation of subgroup analyses.

BRCAm: 74% reduction in the risk of disease progression or death in BRCAm patients with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.259 [95% CI, 0.160–0.421])3

  • Median rPFS was not reached and was at least 30.2 months with TALZENNA + XTANDI + ADT and was 11 months with XTANDI + placebo + ADT1,3
  • 27/71 (38.0%) events with TALZENNA + XTANDI + ADT and 56/84 (66.7%) events with XTANDI + placebo + ADT1,3

Non-BRCAm: 35% reduction in the risk of disease progression or death in non-BRCAm patients with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.651 [95% CI, 0.467–0.906])3

  • Median rPFS was 24.7 months with TALZENNA + XTANDI + ADT and 16.6 months with XTANDI + placebo + ADT1,3
  • 72/129 (55.8%) events with TALZENNA + XTANDI + ADT and 71/115 (61.7%) events with XTANDI + placebo + ADT1,3
rPFS analysis by subgroup was not evaluated for statistical significance; therefore, the results are descriptive in nature only.

ADT, androgen deprivation therapy; CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group performance status; HR, hazard ratio; HRR, homologous recombination repair; HRRm, homologous recombination repair gene-mutated; mCRPC, metastatic castration-resistant prostate cancer; ORR, objective response rate; OS, overall survival; PSA, prostate-specific antigen; rPFS, radiographic progression-free survival.The overall HR for all patients, and by BRCA1/2 alteration status, was based on a Cox proportional hazards model stratified by the randomization stratification factors. For all other subgroups, the HR was based on an unstratified Cox model with treatment as the only covariate. Data are presented as HRs with two-sided 95% CIs.2Two patients received prior orteronel.2Excludes 4 patients who did not have HRR gene alterations, but were incorrectly randomized to the HRR-deficient population.2References:TALZENNA [package insert] for Soft Gelatin Capsule. New York, NY: Pfizer Inc. Fizazi K, Azad AA, Matsubara N, et al. First-line talazoparib with enzalutamide in HRR-deficient metastatic castration-resistant prostate cancer: the phase 3 TALAPRO-2 trial. Nat Med 2024;30(1):257-64. Data on file. Pfizer Inc., New York, NY. Efficacy See OS results from TALAPRO-2 See the data Loading Review safety results from TALAPRO-2 Learn more Loading

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INDICATION

TALZENNA (talazoparib) is indicated in combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

IMPORTANT SAFETY INFORMATION

WARNINGS and PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, has been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in 0.4% (3 out of 788) of solid tumor patients treated with TALZENNA as a single agent in clinical studies. In TALAPRO-2, MDS/AML occurred in 2 out of 511 (0.4%) patients treated with TALZENNA and enzalutamide and in 0 out of 517 (0%) patients treated with placebo and enzalutamide. The durations of TALZENNA treatment in these five patients prior to developing MDS/AML were 0.3, 1, 2, 3, and 5 years, respectively. Most of these patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy.

Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous chemotherapy. Monitor blood counts monthly during treatment with TALZENNA. For prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If counts do not recover within 4 weeks, refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue TALZENNA.

Myelosuppression consisting of anemia, neutropenia, and/or thrombocytopenia have been reported in patients treated with TALZENNA. In TALAPRO-2, Grade ≥3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 45%, 18%, and 8% of patients receiving TALZENNA and enzalutamide. Overall, 39% of patients (199/511) required a red blood cell transfusion, including 22% (111/511) who required multiple transfusions. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 7%, 3%, and 0.4% of patients.

Withhold TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. Monitor blood counts monthly during treatment with TALZENNA. If hematological toxicities do not resolve within 28 days, discontinue TALZENNA and refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics.

Embryo-Fetal Toxicity TALZENNA can cause fetal harm when administered to pregnant women. Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment with TALZENNA and for 4 months after receiving the last dose. 

ADVERSE REACTIONS

Serious adverse reactions reported in >2% of patients included anemia (9%) and fracture (3%). Fatal adverse reactions occurred in 1.5% of patients, including pneumonia, COVID infection, and sepsis (1 patient each).

The most common adverse reactions (≥ 10%, all Grades), including laboratory abnormalities, for patients in the TALAPRO-2 study who received TALZENNA in combination with enzalutamide vs patients receiving placebo with enzalutamide were hemoglobin decreased (79% vs 34%), neutrophils decreased (60% vs 18%), lymphocytes decreased (58% vs 36%), fatigue (49% vs 40%), platelets decreased (45% vs 8%), calcium decreased (25% vs 11%), nausea (21% vs 17%), decreased appetite (20% vs 14%), sodium decreased (22% vs 20%), phosphate decreased (17% vs 13%), fractures (14% vs 10%), magnesium decreased (14% vs 12%), dizziness (13% vs 9%), bilirubin increased (11% vs 7%), potassium decreased (11% vs 7%), and dysgeusia (10% vs 4.5%).

Clinically relevant adverse reactions in <10% of patients who received TALZENNA with enzalutamide included abdominal pain (9%), vomiting (9%), alopecia (7%), dyspepsia (4%), venous thromboembolism (3%) and stomatitis (2%).

Based on animal studies, TALZENNA may impair fertility in males of reproductive potential.

DRUG INTERACTIONS

Coadministration with P-gp inhibitors The effect of coadministration of P-gp inhibitors on talazoparib exposure when TALZENNA is taken in combination with enzalutamide has not been studied. Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a P-gp inhibitor.

Coadministration with BCRP inhibitors Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a BCRP inhibitor. Coadministration of TALZENNA with BCRP inhibitors may increase talazoparib exposure, which may increase the risk of adverse reactions.

USE IN SPECIFIC POPULATIONS

Renal Impairment The recommended dosage of TALZENNA for patients with moderate renal impairment (CLcr 30 - 59 mL/min) is 0.35 mg taken orally once daily in combination with enzalutamide. The recommended dosage of TALZENNA for patients with severe renal impairment (CLcr 15 - 29 mL/min) is 0.25 mg taken orally once daily in combination with enzalutamide. No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis.

Please see the Full Prescribing Information for soft gelatin capsules and hard capsules for TALZENNA.

Please see the XTANDI Prescribing Information for safety information about XTANDI.

INDICATION
TALZENNA (talazoparib) is indicated in combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).