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AboutAboutmCRPCMOATALAPRO-2 Study DesignBaseline Patient CharacteristicsHRRm Testing

HRRm Testing

Why and when to test

How to test

EfficacyEfficacyrPFSrPFS in patient subgroupsORRPSASafetySafetyAdverse reactionsWarnings and precautionsDosingDosingDose modificationsTherapy management strategiesSupportSupportCoverage and accessPatient supportResourcesContact a rep
Prescribing InformationIndicationPatient 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 + XTANDI + ADT COMPARED WITH  PLACEBO + XTANDI  + ADT IN PATIENTS WITH HRRm mCRPC§||

(HR = 0.45 [95% CI, 0.33-0.61]; P < 0.0001)1
• Number of rPFS events by BICR: 66 (33%) with TALZENNA + XTANDI + ADT vs 104 (52%) with placebo + XTANDI + ADT1 

The OS data were not mature at the time of the rPFS analysis.

 TALAPRO-2 Study Design Loading Talazoparib (TALZENNA) + enzalutamide (XTANDI) is the only PARPi + ARi recommended by the NCCN Guidelines® as a Category 1 treatment option for certain patients with HRRm mCRPC.1,4
  • Patients who have had no prior docetaxel or prior NHT (Category 1*)2
  • Patients who have had prior docetaxel and no prior NHT (Category 2A†)2
  • Patients who have had prior NHT and no prior docetaxel (Category 2B‡)2
  1. Pfizer note: The TALAPRO-2 study excluded patients with prior treatment with enzalutamide, apalutamide, or  darolutamide in mCSPC. Prior treatment with docetaxel or a CYP17 inhibitor (including abiraterone) for mCSPC 
  2. was permitted.1,6
Example Text 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 confirmed
  • Myelosuppression: TALZENNA may affect hematopoiesis and can cause anemia, neutropenia, and/or thrombocytopenia
  • Embryo-Fetal Toxicity: TALZENNA can cause fetal harm. Advise of the potential risk to the fetus and to use effective contraception


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


 TALAPRO-2 EFFICACY

Find out more about the primary efficacy endpoint in TALAPRO-2: radiographic progression-free survival1

 See moreLoading SAFETY

The safety profile of TALZENNA + XTANDI was demonstrated in the TALAPRO-2 study1

 See moreLoading DOSING & ADMINISTRATION

Access information about TALZENNA once-daily oral dosing with no fasting or food restrictions1

 See moreLoadingReferences1L, first line; ADT, androgen deprivation therapy; ARi, androgen receptor inhibitor; BICR, blinded independent central review; CI, confidence interval; HR, hazard ratio; HRRm, homologous recombination repair gene-mutated; mCSPC, metastatic castration-sensitive prostate cancer; NCCN, National Comprehensive Cancer Network; PARPi, poly (adenosine diphosphate-ribose) polymerase inhibitor.ReferencesA Category 1 recommendation is based on high-level evidence and indicates uniform NCCN consensus that the intervention is appropriate.2Category 2A recommendation is based upon lower-level evidence and indicates there is uniform NCCN consensus that the intervention is appropriate.2Category 2B recommendation is based upon lower-level evidence and indicates there is NCCN consensus that the intervention is appropriate.2All 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.3,5References:TALZENNA [package insert]. New York, NY: Pfizer Inc. Referenced with Permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2023. © 2023 National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed September 7, 2023. To view the most recent and complete version of the guidelines, 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.XTANDI [package insert]. Northbrook, IL: Astellas Pharma US, Inc.Pfizer Inc. Talazoparib + enzalutamide vs. enzalutamide monotherapy in mCRPC (TALAPRO-2). ClinicalTrials.gov identifier: NCT03395197. https://clinicaltrials.gov/ct2/show/record/NCT03395197?view=record. Updated May 19, 2023. Accessed July 27, 2023.Data on file. Pfizer Inc., New York, NY.

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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 (ARs)

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%) in combination with enzalutamide, including laboratory abnormalities, are hemoglobin decreased, neutrophils decreased, lymphocytes decreased, fatigue, platelets decreased, calcium decreased, nausea, decreased appetite, sodium decreased, phosphate decreased, fractures, magnesium decreased, dizziness, bilirubin increased, potassium decreased, and dysgeusia.

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 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).