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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
    Support & OrderSupport & Order

    EventsVideosMaterialsAccess & Patient Support

    Safety profile

    TALZENNA offers proven safety and tolerability

    Adverse Reactions* (in ≥20% of Patients Receiving TALZENNA) in EMBRACA1

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

    • 25.2% of patients who received TALZENNA experienced alopecia, of which 22.7% was Grade 1# (hair loss of <50%) and 2.4% was Grade 2** (hair loss of ≥50%) vs 27.8% of patients who received chemotherapy (19.8% Grade 1; 7.9% Grade 2)1-3

        CTCAE=Common Terminology Criteria for Adverse Events; NCI=National Cancer Institute.

        *Graded according to NCI CTCAE 4.03.

        †Capecitabine, eribulin, gemcitabine, or vinorelbine.

        ‡Includes anemia, hematocrit decreased, hemoglobin decreased, and red blood cell count decreased.

        §Includes febrile neutropenia, neutropenia, and neutrophil count decreased.

        ||Includes thrombocytopenia and platelet count decreased.

        ¶Includes fatigue and asthenia.

        #Grade 1 defined as hair loss of <50% of normal for that individual that is not obvious from a distance but only on close inspection. A different hairstyle may be required to cover the hair loss, but it does not require a wig or hairpiece to camouflage.3

      **Grade 2 defined as hair loss of ≥50% of normal for that individual that is readily apparent to others. A wig or hairpiece is necessary if the patient desires to completely camouflage the hair loss​​​​​​​.​​​​​​​3

    Announcement Title

    The most common hematologic adverse reactions to TALZENNA were transient4

    With appropriate management, the median duration of Grade 3-4 anemia, neutropenia, and thrombocytopenia was ≤8 days vs ≤18 days with chemotherapy4

    ​​​​​​​The majority of nonhematologic adverse events in the TALZENNA group were Grade 1 in severity6

    • The median duration of study treatment was 6.1 months in patients who received TALZENNA and 3.9 months in patients who received chemotherapy1​​​​​​​

    Laboratory abnormalities

    Laboratory Abnormalities Reported in ≥25% of Patients in EMBRACA1​​​​​​​

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

     **This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.

    ​​​​​​​‡‡This number represents non-fasting glucose.​​​​​​​

    Discontinuations and dose reductions

    • 95% of patients did not discontinue TALZENNA due to an adverse reaction1

    • Permanent discontinuation due to an adverse reaction occurred in 5% of patients receiving TALZENNA vs 6% of patients on chemotherapy1

    • Most adverse events were managed with dose interruption/reduction or standard supportive medical therapy4,6

    • The median time to first dose reduction due to an adverse reaction was 19.3 weeks for TALZENNA vs 9.3 weeks with oral chemotherapy (capecitabine)4,5 
      • ​​​​​​​Dose interruptions due to an adverse reaction of any grade occurred in 65% of patients receiving TALZENNA and 50% of those receiving chemotherapy1
      • ​​​​​​​Dose reductions due to any cause occurred in 53% of TALZENNA patients and 40% of chemotherapy patients1

    Warnings and Precautions

    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.1

    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.1

    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.1

    Embryo-fetal toxicity
    Based on its mechanism of action and findings from animal data, TALZENNA can cause fetal harm when administered to a pregnant woman.1

    • Apprise pregnant women and females of reproductive potential of the potential risk to a fetus1
    • Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of TALZENNA1
    • Based on findings from genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for at least 4 months following the last dose of TALZENNA1

    References:
    1. TALZENNA [prescribing information]. New York, NY: Pfizer Inc.; 2020.
    2. 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.
    3. National Institutes of Health, US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Bethesda, MD: National Institutes of Health. Revised June 2010, version 4.03. NIH publication 09-5410.
    4. Hurvitz SA, Goncalves A, Rugo HS, et al. Talazoparib in patients with a germline BRCA‐mutated advanced breast cancer: detailed safety analyses from the phase III EMBRACA trial. Oncologist. 2019;24:1-12. doi:10.1634/theoncologist.2019-0493.
    5. Data on File. Pfizer, Inc, New York, NY.
    6. 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.

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

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    Card CTA

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

    Efficacy & Safety

    • Study Design
    • Efficacy
    • Safety Profile

    Identifying patients with gBRCA ​​​​​​​mutations

    Learn about the guidelines for g​​​​​​​BRCA testing

    View testing guidelines

    ** 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.

    Demonstrated clinical benefit​​​​​​​1

    The efficacy of TALZENNA was evaluated in an open-label, 2:1 randomized Phase 3 study​​​​​​​1,6

    Review efficacy data

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

    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.