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Prescribing InformationIndicationLoadingPatient SiteSee Information on a Different Indication
Now approved in HRRm mAPMN/S prostate cancer (also known as HRRm mCSPC)1
Now approved in HRRm mAPMN/S prostate cancer (also known as HRRm mCSPC)1
Treating early in BRCAm and non-BRCA HRRm mCSPC matters2Starting with TALZENNA + XTANDI can make a measurable difference with a powerful combination proven to help patients live progression free longer vs XTANDI alone in HRRm mCSPC*1,3 TALAPRO-3 | Statistically significant rPFS† (primary endpoint): 52% reduction in the risk of disease progression or death with TALZENNA + XTANDI

vs XTANDI + placebo (HR = 0.48 [95% CI, 0.36–0.65]; P < 0.0001)1,3

rPFS events by investigator: 67/300 (22%) with TALZENNA + XTANDI + ADT vs 126/299 (42%) with XTANDI + placebo + ADT1,3

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TALAPRO-3 is a phase 3, randomized, double-blind, placebo-controlled study comparing TALZENNA + XTANDI (n = 300) vs XTANDI + placebo (n = 299) in patients with HRRm mCSPC.‡1,3

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS SUMMARY

  • Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML occurred in patients exposed to TALZENNA, and some cases were fatal. Monitor patients for hematological toxicity and discontinue if MDS/AML is confirmed1
  • Myelosuppression: TALZENNA may affect hematopoiesis and can cause anemia, leukopenia/neutropenia, and/or thrombocytopenia1
  • Embryo-Fetal Toxicity: TALZENNA can cause fetal harm. Advise of the potential risk to the fetus and to use effective contraception1
Please see additional information about these Warnings and Precautions and additional Important Safety Information below. TALZENNA + XTANDI was also evaluated in BRCAm and non-BRCA HRRm mAPMR prostate cancer (also known as HRRm mCRPC) in TALAPRO-2—explore the results1 Efficacy in HRRm mCRPC Loading Safety in HRRm mCRPC Loading Efficacy in HRRm mCRPC Loading Safety in HRRm mCRPC LoadingReferencesrPFS was defined as the time from the date of randomization to first objective evidence of radiographic progression in soft tissue per Response Evaluation Criteria in Solid Tumors version 1.1 or in bone per Prostate Cancer Working Group 3 criteria by the investigator, or death, whichever occurred first.3ADT, androgen deprivation therapy; CI, confidence interval; HR, hazard ratio; HRR, homologous recombination repair; HRRm, homologous recombination repair gene-mutated; mAPMN/S, metastatic androgen pathway modulator-naive or -sensitive; mAPMR, metastatic androgen pathway modulation-resistant; mCRPC, metastatic castration-resistant prostate cancer; mCSPC, metastatic castration-sensitive prostate cancer; rPFS, radiographic progression-free survival.Overall survival data were not mature at the time of the final rPFS analysis.3Patients were required to have an alteration in at least one of 12 genes involved directly or indirectly in the HRR pathway: ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, and RAD51C.1References:TALZENNA [package insert]. New York, NY: Pfizer Inc.; October 2026. Olmos D, Lorente D, Jambrina A, et al. BRCA1/2 and homologous recombination repair alterations in high- and low-volume metastatic hormone-sensitive prostate cancer: prevalence and impact on outcomes. Ann Oncol 2025;36(10):1190-1202. Agarwal N, Matsubara N, Azad AA, et al. PARP and androgen-signaling inhibition plus ADT in metastatic prostate cancer. N Engl J Med 2026;395(5):427-39.

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INDICATIONS

TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with:

  • Metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer with homologous recombination repair gene mutations (HRRm), as detected by an FDA-authorized test
  • Metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer with homologous recombination repair gene mutations (HRRm), as detected by an FDA-authorized test
IMPORTANT SAFETY INFORMATIONWARNINGS AND PRECAUTIONSMyelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, has been reported in patients who received TALZENNA. In clinical studies, among 1,096 patients treated with TALZENNA as a single agent or as part of a combination regimen with enzalutamide, the cumulative incidence of MDS/AML was approximately 1% including 0.6% with fatal outcomes. The incidence of MDS/AML among patients treated with active control or with placebo in combination with enzalutamide was 0.2%. The median duration of therapy with TALZENNA in patients who developed MDS/AML was approximately 2.8 years (range: 1 to 5.8 years).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, leukopenia/neutropenia, and/or thrombocytopenia has been reported in patients treated with TALZENNA. Grade ≥ 3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 49%, 19%, and 9% of patients receiving TALZENNA in combination with enzalutamide. Forty-one percent of patients required a red blood cell transfusion, including 25% who required more than one transfusion. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 7%, 4%, and 1% 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 a pregnant woman. 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 REACTIONSIn the pooled safety population of 810 patients with prostate cancer, the most common (≥ 20%) adverse reactions including laboratory abnormalities were decreased hemoglobin (86%), decreased neutrophils (68%), decreased lymphocytes (62%), decreased platelets (54%), fatigue (48%), decreased albumin (26%), decreased calcium (26%), back pain (24%), decreased appetite (22%), and nausea (21%).DRUG INTERACTIONSCoadministration 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 POPULATIONSMales of Reproductive Potential Based on animal studies, TALZENNA may impair fertility.Renal Impairment Reduce the recommended dosage of TALZENNA in patients with moderate (CLcr 30 - 59 mL/min) and severe (CLcr 15 - 29 mL/min) renal impairment. 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 TALZENNA. Please see the XTANDI Prescribing Information for safety information about XTANDI.

INDICATIONSTALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with:
  • Metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer with homologous recombination repair gene mutations (HRRm), as detected by an FDA-authorized test
  • Metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer with homologous recombination repair gene mutations (HRRm), as detected by an FDA-authorized test