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    AboutAbout

    Mechanism of ActionNCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)Identifying Patients With gBRCA Mutations
    Efficacy & SafetyEfficacy & SafetyStudy DesignEfficacySafety profileDosingDosing

    Dosing and Modifications
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    Study Design

    EMBRACA: the largest Phase 3, open-label study of a PARP inhibitor monotherapy in gBRCA-mutated HER2- locally advanced or metastatic breast cancer1-3​​​​​​​

    ** This is an optional area where footnotes can live.

    Additional inclusion criteria:

    • Patients received 0, 1, 2, or 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease
    • Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic setting
    • Patients treated with prior platinum therapy for advanced disease were required to have no evidence of disease progression during platinum therapy
    • No prior treatment with a PARP inhibitor was permitted

    Randomization stratified by:

    • Prior lines of chemotherapy for locally advanced or metastatic disease (0 vs 1, 2, or 3)
    • Hormone receptor status (HR+/HER2- vs TNBC)
    • History of CNS metastases (yes vs no)

    ** This is an optional area where footnotes can live.

         BICR=blinded independent central review; CNS=central nervous system; RECIST=Response Evaluation Criteria in Solid Tumors;

         TNBC=triple-negative breast cancer.

       *Patients had a deleterious or suspected deleterious gBRCA mutation detected using a clinical trial assay.

        †Capecitabine, eribulin, gemcitabine, or vinorelbine.

    Baseline characteristics: TALZENNA was evaluated in a broad range of patients3

    Baseline characteristics (ITT population)

    ** This is an optional area where footnotes can live.

         ABC=advanced breast cancer; ECOG PS=Eastern Cooperative Oncology Group performance status; ITT=intent-to-treat.​​​​​​​

    ​​​​​​​   Only 10 patients (6 and 4 patients in the TALZENNA and standard-therapy groups, respectively) were identified as having a suspected deleterious mutation. The remainder who underwent central testing with BRACAnalysis CDx® had a known pathogenic variant.

    GIVE YOUR PATIENTS A BIOMARKER-DRIVEN TREATMENT THAT'S ​​​​​​​JUST FOR THEM

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    Efficacy & Safety

    • Study Design
    • Efficacy
    • Safety Profile
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    Convenient once-daily dosing​​​​​​​1

    The recommended starting dose of TALZENNA is 1 mg taken orally once daily1

    See dosing information

    ** This is an optional area where footnotes can live.

    Mechanism of action

    TALZENNA is an inhibitor of PARP enzymes, including PARP1 and PARP2, which play a role in DNA repair1

    Review the MOA

    ** This is an optional area where footnotes can live.

    Safety and tolerability profile

    The safety of TALZENNA was evaluated in an open-label, 2:1 randomized Phase 3 study1,3

    Review safety profile

    ** This is an optional area where footnotes can live.


    References:
    1. TALZENNA [prescribing information]. New York, NY: Pfizer Inc.; 2020.
    2. Lynparza [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
    3. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379(8):753-763.
    4. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. doi:10.1056/NEJMoa1802905; supplementary appendix:1-22.

    Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) have been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in 2 out of 584 (0.3%) solid tumor patients treated with TALZENNA in clinical studies. The duration of TALZENNA treatment in these two patients prior to developing MDS/AML was 4 months and 24 months, respectively. Both patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy.

    Myelosuppression consisting of anemia, leukopenia/neutropenia, and/or thrombocytopenia have been reported in patients treated with TALZENNA. Grade ≥3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 39%, 21%, and 15% of patients receiving TALZENNA. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 0.7%, 0.3%, and 0.3% of patients.

    Monitor complete blood counts for cytopenia at baseline and monthly thereafter. Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. If hematological toxicity occurs, dose modifications (dosing interruption with or without dose reduction) are recommended. With respect to MDS/AML, for prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If the levels have not recovered after 4 weeks, refer the patient to a hematologist for further investigations. If MDS/AML is confirmed, discontinue TALZENNA.

    TALZENNA can cause fetal harm when administered to pregnant women. Advise women of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose. A pregnancy test is recommended for females of reproductive potential prior to initiating TALZENNA treatment. Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment with TALZENNA and for at least 4 months after receiving the last dose. Based on animal studies, TALZENNA may impair fertility in males of reproductive potential. Advise women not to breastfeed while taking TALZENNA and for at least 1 month after receiving the last dose because of the potential for serious adverse reactions in nursing infants.

    The most common adverse reactions (≥20%) of any grade for TALZENNA vs chemotherapy were fatigue (62% vs 50%), anemia (53% vs 18%), nausea (49% vs 47%), neutropenia (35% vs 43%), headache (33% vs 22%), thrombocytopenia (27% vs 7%), vomiting (25% vs 23%), alopecia (25% vs 28%), diarrhea (22% vs 26%), and decreased appetite (21% vs 22%).

    The most frequently reported Grade ≥3 adverse reactions (≥10%) for TALZENNA vs chemotherapy were anemia (39% vs 5%), neutropenia (21% vs 35%), and thrombocytopenia (15% vs 2%).

    The most common lab abnormalities (≥25%) for TALZENNA vs chemotherapy were decreases in hemoglobin (90% vs 77%), leukocytes (84% vs 73%), lymphocytes (76% vs 53%), neutrophils (68% vs 70%), platelets (55% vs 29%), and calcium (28% vs 16%) and increases in glucose (54% vs 51%), aspartate aminotransferase (37% vs 48%), alkaline phosphatase (36% vs 34%), and alanine aminotransferase (33% vs 37%).

    Coadministration with P-gp inhibitors or BCRP inhibitors may increase TALZENNA exposure. If coadministering with the P-gp inhibitors amiodarone, carvedilol, clarithromycin, itraconazole, or verapamil is unavoidable, reduce the TALZENNA dose to 0.75 mg once daily. When the P-gp inhibitor is discontinued, increase the TALZENNA dose (after 3–5 half-lives of the P-gp inhibitor) to the dose used prior to the initiation of the P-gp inhibitor. When coadministering TALZENNA with other known P-gp inhibitors or BCRP inhibitors, monitor patients for potential increased adverse reactions.

    For patients with moderate renal impairment, the recommended dose of TALZENNA is 0.75 mg once daily. For patients with severe renal impairment, the recommended dose of TALZENNA is 0.5 mg once daily. No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis.

    TALZENNA has not been studied in patients with moderate or severe hepatic impairment. No dose adjustment is required for patients with mild hepatic impairment.

    TALZENNA is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA ​​​​​.

    Please see full Prescribing Information.

    Indication

    TALZENNA is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.