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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
HRR Testing May Help Identify Appropriate mCRPC Patients for TALZENNA + XTANDI1It is important to test your patients with mCRPC for HRR gene alterations
  • Select patients for the treatment of HRR gene-mutated mCRPC with TALZENNA + XTANDI 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, or RAD51C1
  • In the TALAPRO-2 study, assessment of HRR gene alteration status by prospective analysis for patients treated with TALZENNA + XTANDI was determined using next-generation sequencing (NGS)-based tumor tissue and circulating tumor DNA (ctDNA) tests1
An FDA-approved test for the detection of HRR gene alterations for use with TALZENNA is not currently available.1 WHOM TO TEST

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend germline and somatic tumor testing for HRR gene alterations in all patients with metastatic prostate cancer.*2

 WHEN TO TEST

NCCN Guidelines® recommend multigene tumor testing for somatic HRR gene alterations upon metastatic prostate cancer diagnosis, and retesting may be considered upon progression to mCRPC.2

Germline multigene HRRm testing is recommended in patients with metastatic prostate cancer, if not
previously performed.2

 WHICH TYPE OF TEST

Consider requesting a multigene NGS test or panel that includes HRR alterations.1

 WHOM to test

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend germline and somatic tumor testing for HRR gene alterations in all patients with metastatic prostate cancer.*2

 WHEN to test

NCCN Guidelines® recommend multigene tumor testing for somatic HRR gene alterations upon metastatic prostate cancer diagnosis, and retesting may be considered upon progression to mCRPC.2

Germline testing is recommended in certain patients with prostate cancer; a positive family history of certain cancers or familial cancer risk mutation; and high- or very high-risk localized, regional (node-positive), or metastatic prostate cancer.2,3

 WHICH type of test

Consider requesting a multigene NGS test or panel that includes HRR gene alterations.1

ReferencesGermline mutations are inherited mutations passed from parent to child and are found in nucleated cells in the body (including the tumor); somatic tumor mutations (typically found in tumor cells) develop during the life of the patient.4,5
Test all your patients with mCRPC for HRR gene alterations
Use a test that is right for your patient.
HRRm status can be both prognostic and predictive2,6HRRm status can be both prognostic and predictive2,6

Based on a comprehensive review of multiple studies and/or pooled datasets reporting the prevalence in mCRPC.7-10 

  • In TALAPRO-2, more than 50% of HRR alterations were not BRCA1/211
  • NCCN Guidelines recommend multigene tumor testing to assess HRR alterations2

 

Testing your patients with mCRPC for HRR gene alterations can help: IDENTIFY PATIENTS with a worse overall prognosis2,12,13 IDENTIFY APPROPRIATE TREATMENT     options2 IDENTIFY APPROPRIATE TREATMENT options2 IDENTIFY FAMILY MEMBERS

at increased risk of cancer2

  • Test tissue or liquid samples for HRR alterations using a comprehensive multigene panel that includes BRCA1, BRCA2, ATM, ATR, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, and RAD51C1
Consider testing for HRR gene alterations upon metastatic diagnosis and progression to mCRPC

NCCN Guidelines recommend germline and somatic tumor testing for HRR gene alterations in all patients with metastatic prostate cancer2
  • Germline multigene HRRm testing (if not performed previously) is recommended, which may include genes such as BRCA1, BRCA2, ATM, CHEK2, HOXB13, and TP53, in patients with mCRPC3
  • Somatic testing is recommended using multigene tumor testing for alterations in homologous recombination DNA repair genes, such as BRCA1, BRCA2, ATM, RAD51D, PALB2, FANCA, CHEK2, and CDK12, in patients with metastatic prostate cancer2

The American Urological Association® (AUA) recommends that clinicians offer germline testing (if not already performed) and somatic multigene testing to identify DNA repair deficiency, MSI status, tumor mutational burden, and other potential mutations that may inform prognosis and familial cancer risk, as well as direct potential targeted therapies, for patients with mCRPC6

 HRR, homologous recombination repair; HRRm, homologous recombination repair gene-mutated; mCRPC, metastatic castration-resistant prostate cancer; MSI, microsatellite instability; NCCN, National Comprehensive Cancer Network; rPFS, radiographic progression-free survival.References: TALZENNA [package insert] for Soft Gelatin Capsule. New York, NY: Pfizer Inc. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V1.2025. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed December 9, 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. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Genetic/Familial High-Risk Assessment: Breast, Ovarian, Pancreatic, and Prostate V2.2025 © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed November 21, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. Cheng HH, Sokolova AO, Schaeffer EM, Small EJ, Higano CS. Germline and somatic mutations in prostate cancer for the clinician. J Natl Compr Canc Netw 2019;17(5):515-21. Grossmann S, Hooks Y, Wilson L, et al. Development, maturation, and maintenance of human prostate inferred from somatic mutations. Cell Stem Cell 2021;28(7):1262-1274.e5.Lowrance W, Dreicer R, Jarrard DF, et al. Updates to advanced prostate cancer: AUA/SUO guideline (2023). J Urol 2023;209(6):1082-90. Chung JH, Dewal N, Sokol E. Prospective comprehensive genomic profiling of primary and metastatic prostate tumors. JCO Precis Oncol 2019;3:PO.18.00283. de Bono JS, Mehra N, Scagliotti GV, et al. Talazoparib monotherapy in metastatic castration-resistant prostate cancer with DNA repair alterations (TALAPRO-1): an open-label, phase 2 trial. Lancet Oncol 2021;22(9):1250-64. Lang SH, Swift SL, White H, Misso K, Kleijnen J, Quek RGW. A systematic review of the prevalence of DNA damage response gene mutations in prostate cancer. Int J Oncol 2019;55(3):597-616.Kim IE Jr, Kim S, Srivastava A, et al. Similar incidence of DNA damage response pathway alterations between clinically localized and metastatic prostate cancer. BMC Urol 2019;19(1):33. 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. Plym A, Dióssy M, Szallasi Z, et al. DNA repair pathways and their association with lethal prostate cancer in African American and European American men. JNCI Cancer Spectr 2021;6(1):pka087. Castro E, Romero-Laorden N, del Pozo A, et al. PROREPAIR-B: a prospective cohort study of the impact of germline DNA repair mutations on the outcomes of patients with metastatic castration-resistant prostate cancer. J Clin Oncol 2019;37(6):490-503.HRRm Testing See rPFS results from TALAPRO-2

Including exploratory subgroup analyses in patients with BRCA and non-BRCA gene alterations

 See the data LoadingLearn how to test for HRR alterations Learn moreLoading

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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).