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AboutAboutUnmet needs in HRRm mCRPCMOATALAPRO-2 study designBaseline patient characteristicsTreatment guidelinesHRRm Testing

HRRm Testing

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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
TALZENNA + XTANDI Safety in the TALAPRO-2 StudyAdverse reactions (≥ 10%) in patients receiving TALZENNA with a ≥ 2% difference between treatment arms in the TALAPRO-2 study1 ReferencesNCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.ReferencesGraded according to NCI CTCAE 4.03.1Includes fatigue and asthenia.1Fractures include multiple similar terms.1Includes dizziness, dizziness postural, vertigo.1Includes ageusia, anosmia, and dysgeusia.1
  • Clinically relevant adverse reactions in < 10% of patients who received TALZENNA + XTANDI included abdominal pain (9%), vomiting (9%), alopecia (7%), dyspepsia (4%), venous thromboembolism (3%), and stomatitis (2%)1
  • Serious adverse reactions occurred in 30% of patients receiving TALZENNA + XTANDI1
    • Serious adverse reactions reported in > 2% of patients included anemia (9%) and fracture (3%)
    • Fatal adverse reactions occurring in 1.5% of patients included pneumonia, COVID infection, and sepsis (1 patient each)
  • 86% of patients received TALZENNA for ≥ 6 months, 60% for > 1 year, and 18% for > 2 years1

Refer to the XTANDI Prescribing Information for adverse reactions associated with XTANDI.

Select laboratory abnormalities (≥ 10%) that worsened from baseline in patients who received TALZENNA + XTANDI in TALAPRO-21 ReferencesThe denominator used to calculate the rate varied from 198 to 199 in the XTANDI + placebo arm based on the number of patients with a baseline value and at least 1 post-treatment value.1
  • The median time to onset of first Grade 3/4 anemia was 3.3 months for patients who received TALZENNA + XTANDI2
  • In TALAPRO-2, Grade ≥ 3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 45%, 18%, and 8% of patients receiving TALZENNA + XTANDI. 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 patients1

Refer to the XTANDI Prescribing Information for laboratory abnormalities associated with XTANDI.

In TALAPRO-2, TALZENNA dose modifications were permitted to help manage adverse reactions1
  • To manage adverse reactions, consider interruption of treatment with or without dose reduction based on severity and clinical presentation1
 Most patients did not require permanent discontinuation of TALZENNA due to adverse reactions1
  • The most common adverse reactions that resulted in permanent discontinuation of TALZENNA were anemia (4%), fatigue, bone fracture, ischemic heart disease, and spinal cord compression (1% each)1
  • 7% of patients in the XTANDI + placebo arm required permanent discontinuation due to adverse reactions2
ReferencesSee Dosing for information about dose reduction.Please see XTANDI Prescribing Information for dosing information about XTANDI.References:TALZENNA [package insert] for Soft Gelatin Capsule. 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.Safety See therapy management strategies

Including dose modifications and adverse reaction management

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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).