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EfficacyEfficacyOSOS in patient subgroupsrPFS: Primary and follow-uprPFS in patient subgroupsORRPSASafetySafetyWarnings 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
Overall survival in patient subgroups, including BRCAm and non-BRCA HRRm1,2 BRCAm mCRPC: median OS not reached with TALZENNA + XTANDI in follow-up analysis*1,2
Median OS was not reached and was at least 35.4 months with TALZENNA + XTANDI1,2
52% reduction in the risk of death with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.48 [95% CI, 0.31–0.75])1,2
  • OS events: 30/71 (42%) with TALZENNA + XTANDI + ADT and 56/84 (67%) with XTANDI + placebo + ADT1
  • At 48 months, it is estimated that 53% of patients randomized to TALZENNA + XTANDI + ADT therapy and 23% of patients randomized to XTANDI + placebo + ADT therapy were alive according to Kaplan-Meier calculations.2 This was not a prespecified analysis and is not included in the USPI for TALZENNA
 Non-BRCA HRRm mCRPC: median OS of 3.5 years with TALZENNA + XTANDI*1,2
Observed median OS was 9.8 months longer than XTANDI + placebo1,2
29% reduction in the risk of death with TALZENNA + XTANDI vs XTANDI + placebo (HR = 0.71 [95% CI, 0.51–1.00])1,2
  • OS events: 63/129 (49%) with TALZENNA + XTANDI + ADT vs 70/115 (61%) with XTANDI + placebo + ADT1
  • At 48 months, it is estimated that 46% of patients randomized to TALZENNA + XTANDI + ADT therapy and 33% of patients randomized to XTANDI + placebo + ADT therapy were alive according to Kaplan-Meier calculations.2 This was not a prespecified analysis and is not included in the USPI for TALZENNA
  • Non-BRCA alterations assessed at baseline in TALAPRO-2 were ATM, ATR, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, and RAD51C1,2
 Post hoc exploratory analyses: overall survival by HRR gene alteration subgroup2 The “All patients” group is included in the TALZENNA USPI; all other subgroups are not included in the TALZENNA USPI. Subgroup analyses by HRR gene alterations are post hoc and exploratory. Small sample size is a limitation of these subgroup analyses.
  • This analysis uses all available tumor and prescreening/screening ctDNA records, including records generated after the randomization date2
  • For the subgroups of patients with non-BRCA HRR gene alterations, patients with co-occurring BRCA1 or BRCA2 alterations were excluded. For the subgroup of patients with BRCA1 alterations, patients with co-occurring BRCA2 alterations were excluded2
  • Patients with co-alterations in multiple genes not including BRCA1/2 are counted under each individual corresponding gene subgroup2
 Subgroup analysis of overall survival by baseline characteristics§2 The information below is not included in the TALZENNA USPI. These descriptive analyses were prespecified but not alpha protected per the statistical analysis plan. Small sample size is a limitation of these subgroup analyses.
  • Patients in the TALAPRO-2 study were stratified by prior treatment with a CYP17 inhibitor (including abiraterone) or docetaxel (yes/no)1–3
ReferencesThe term “alpha protected” used in the disclaimer above refers to a statistical method used in clinical trials to reduce the chance of incorrectly finding a result by chance when testing multiple hypotheses.OS analysis by subgroup was not evaluated for statistical significance; therefore, the results are descriptive in nature only.2

ADT, androgen deprivation therapy; CI, confidence interval; ctDNA, circulating tumor DNA; ECOG PS, Eastern Cooperative Oncology Group performance status; EU, European Union; HR, hazard ratio; HRR, homologous recombination repair; HRRm, homologous recombination repair gene-mutated; mCRPC, metastatic castration-resistant prostate cancer; NR, not reached; ORR, objective response rate; OS, overall survival; PSA, prostate-specific antigen; rPFS, radiographic progression-free survival; UK, United Kingdom.Median follow-up time in the ITT population was ~ 44 months in both treatment arms.2 A hazard ratio does not exist for select subgroups in these analyses due to at least 1 of the treatment arms having 0 events.Hazard ratio for all patients was based on a Cox model stratified by the randomization stratification factors. For all subgroups, hazard ratio was based on an unstratified Cox model with treatment as the only covariate.2With or without PSA progression.2Two patients received prior orteronel.2References:TALZENNA [package insert]. New York, NY: Pfizer Inc.; June 2025. Fizazi K, Azad AA, Matsubara N, et al. Talazoparib plus enzalutamide in men with HRR-deficient metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet 2025;406(10502):461-74.Data on file. Pfizer Inc., New York, NY.Efficacy See primary rPFS results from TALAPRO-2 See the data Loading Review the study design for TALAPRO-2
Review key criteria, including baseline HRR gene alteration status
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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 5 patients prior to developing MDS/AML were 0.3, 1, 2, 3, and 5 years. 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 48%, 19%, and 9% of patients receiving TALZENNA and enzalutamide. Forty-two percent of patients (216/511) required a red blood cell transfusion, including 25% (127/511) who required more than one transfusion. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 8%, 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 and for 4 months following the last dose of TALZENNA.
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 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%).
DRUG INTERACTIONS

Coadministration with P-gp inhibitors The effect of coadministration of P-gp inhibitors on talazoparib exposure when TALZENNA is taken 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

Males of Reproductive Potential Based on animal studies, TALZENNA may impair fertility.

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 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 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.
INDICATIONTALZENNA (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).