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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
How to Test for HRR AlterationsSomatic multigene tumor testing at progression to mCRPC is recommended to inform treatment options1Somatic multigene tumor testing at progression to mCRPC is recommended to inform treatment options1

Germline mutations (or inherited mutations) are passed from parent to child and are found in every cell in the body, including those in the tumor2

Somatic tumor mutations (or acquired mutations) develop during the life of the patient and are found in tumor cells2,3

Germline mutations (or inherited mutations) are passed from parent to child and are found in every cell in the body, including those in the tumor2,3

Somatic tumor mutations (or acquired mutations) develop during the life of the patient and are typically found in tumor cells3

  • Both germline tumor and somatic tumor HRR gene alterations can exist within prostate cancer tumors4
  • If a patient has only been tested for germline mutations in earlier stages of disease, somatic tumor mutation testing may identify acquired HRR gene alterations4
There are multiple types of NGS tests to identify HRR gene alterations4

SOLID TUMOR BIOPSY TEST4

Test requirement: tissue from the tumor (preferably recently acquired)5
Types of mutations detected: somatic and germline alterations*

BLOOD PLASMA ctDNA TEST4

Test requirement: blood sample
Types of mutations detected: somatic and germline alterations

GERMLINE-ONLY TEST4

Test requirement: blood sample
Types of mutations detected: only germline alterations

Choose the right test for your patients

There are numerous commercially available tests for HRR gene alterations, or your institution may have its own test available to identify patients with HRRm mCRPC.

An FDA-approved test for the detection of HRR gene alterations for use with TALZENNA is not currently available.6

ReferencesctDNA, circulating tumor DNA; HRR, homologous recombination repair; HRRm, homologous recombination repair gene-mutated; mCRPC, metastatic castration-resistant prostate cancer; NGS, next-generation sequencing; rPFS, radiographic progression-free survival.References*Solid tumor biopsy tests identify both somatic and germline alterations but do not distinguish between somatic tumor and germline alterations.4References: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.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.Scott RJ, Mehta A, Macedo GS, Borisov PS, Kanesvaran R, El Metnawy W. Genetic testing for homologous recombination repair (HRR) in metastatic castration-resistant prostate cancer (mCRPC): challenges and solutions. Oncotarget 2021;12(16):1600-14.Vandekerkhove G, Giri VN, Halabi S, et al. Toward informed selection and interpretation of clinical genomic tests in prostate cancer. JCO Precis Oncol 2024;8:e2300654.TALZENNA [package insert] for Soft Gelatin Capsule. New York, NY: Pfizer Inc.HRRm TestingSee a guidelines recommendation for TALZENNA + XTANDI Learn more Loading See rPFS results from TALAPRO-2

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

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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).