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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

EfficacyEfficacyrPFSrPFS in patient subgroupsORRPSASafetySafetyAdverse reactionsWarnings and precautionsDosingDosingDose 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
TALZENNA (talazoparib) + XTANDI (enzalutamide)TALZENNA is indicated in combination with XTANDI for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC)1

reduction in the risk of radiographic disease progression or death with TALZENNA + XTANDI1,2

Superior rPFS vs XTANDI + placebo in 1L BRCAm and non-BRCA* HRRm mCRPC†‡1,2

HR = 0.45 [95% CI, 0.33-0.61]; P < 0.0001. Number of rPFS events by BICR: 66 (33%) with TALZENNA + XTANDI + ADT vs 104 (52%) with XTANDI + placebo + ADT in TALAPRO-2.1,2

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TALAPRO-2: a phase 3, randomized, double-blind, placebo-controlled, multinational study compared TALZENNA + XTANDI (n = 200) vs XTANDI + placebo (n = 199) in patients with HRR gene-mutated (HRRm) mCRPC.1,2

reduction in the risk of radiographic disease progression or death with TALZENNA + XTANDI1,2

Superior rPFS vs XTANDI + placebo in 1L BRCAm and non-BRCA* HRRm mCRPC†‡1,2

HR = 0.45 [95% CI, 0.33-0.61]; P < 0.0001. Number of rPFS events by BICR: 66 (33%) with TALZENNA + XTANDI + ADT vs 104 (52%) with XTANDI + placebo + ADT in TALAPRO-2.1,2

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TALAPRO-2: a phase 3, randomized, double-blind, placebo-controlled, multinational study compared TALZENNA + XTANDI (n = 200) vs XTANDI + placebo (n = 199) in patients with HRR gene-mutated (HRRm) mCRPC.1,2

Start with TALZENNA + XTANDI, the first and only PARPi + ARi combination for the 1L treatment of BRCAm and non-BRCA* HRRm mCRPC1,2

References*Select patients for the treatment of HRRm mCRPC with TALZENNA based on the presence of alterations in genes directly or indirectly involved in HRR: ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, and RAD51C.1

Start with TALZENNA + XTANDI, the first and only PARPi + ARi combination for the 1L treatment of BRCAm and non-BRCA* HRRm mCRPC1,2

References*Select patients for the treatment of HRRm mCRPC with TALZENNA based on the presence of alterations in genes directly or indirectly involved in HRR: ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, and RAD51C.1
Talazoparib (TALZENNA) + enzalutamide (XTANDI) is the only PARPi + ARi recommended by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for certain patients with HRRm mCRPC§3
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Talazoparib (TALZENNA) + enzalutamide (XTANDI) is the only PARPi + ARi recommended by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for certain patients with HRRm mCRPC§3
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Test patients with mCRPC for HRR alterations1

Select patients for the treatment of HRRm mCRPC with TALZENNA based on the presence of alterations in genes directly or indirectly involved in HRR: ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, and RAD51C

 Know when to test Loading Know when to test Loading IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
  • Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML has been reported in < 1% of solid tumor patients treated with TALZENNA in clinical studies. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed1
  • Myelosuppression: TALZENNA may affect hematopoiesis and can cause anemia, 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

See additional information about these Warnings and Precautions and Important Safety Information in the safety section below.

See key criteria from TALAPRO-2, including baseline HRR gene alteration status

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Review the demonstrated safety profile for TALZENNA + XTANDI from the TALAPRO-2 study

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Learn about TALZENNA once-daily oral dosing with no fasting or food restrictions

 See dosingLoadingReferences1L, first line; ADT, androgen deprivation therapy; ARi, androgen receptor inhibitor; BICR, blinded independent central review; CI, confidence interval; HR, hazard ratio; HRR, homologous recombination repair; mCRPC, metastatic castration-resistant prostate cancer; mCSPC, metastatic castration-sensitive prostate cancer; NCCN, National Comprehensive Cancer Network; PARPi, poly (adenosine diphosphate-ribose) polymerase inhibitor; rPFS, radiographic progression-free survival.All patients received a gonadotropin-releasing hormone (GnRH) analog concurrently or had bilateral orchiectomy.1rPFS was defined as time from the date of randomization to first objective evidence of radiographic progression by blinded independent review, or death (occurring within 168 days of treatment discontinuation), whichever occurs first.4,5NCCN Guidelines® recommend multigene tumor testing to assess HRR alterations, such as BRCA1, BRCA2, ATM, RAD51C, PALB2, FANCA, CHEK2, and CDK12.3References:TALZENNA [package insert]. 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.Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer Version 4.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 20, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.Agarwal N, Azad A, Shore ND, et al. Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: TALAPRO-2 phase III study design. Future Oncol 2022;18(4):425-36.Pfizer Inc. Talazoparib + enzalutamide vs. enzalutamide monotherapy in mCRPC (TALAPRO-2). ClinicalTrials.gov identifier: NCT03395197. Updated April 23, 2024. Accessed June 21, 2024. https://clinicaltrials.gov/study/NCT03395197?tab=table

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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 has 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 (Grade ≥10, all Grades), including laboratory abnormalities, for patients in the TALAPR0-2 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 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).