FDA Approves Trodelvy for Metastatic TNBC

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Moderators Member Posts: 25,912
edited May 2020 in Stage IV/Metastatic Breast Cancer ONLY

Have you been diagnosed with metastatic triple-negative breast cancer that has stopped responding to at least two previous treatments? On April 22, 2020, the FDA granted accelerated approval to Trodelvy (chemical name: sacituzumab govitecan-hziy) to treat adults diagnosed with triple-negative disease.

Read the breaking news story here, and comment with your thoughts below.

Read more about Trodelvy (chemical name: sacituzumab govitecan-hziy).

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  • TrixieBoo
    TrixieBoo Member Posts: 17
    edited April 2020

    My oncologist mentioned this new drug to me today! Very happy to see some new options for us triple negative types

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  • ledascout
    ledascout Member Posts: 17
    edited April 2020

    This drug is also being tested for ER+ disease, and supposed to be very promising there. So glad to have another option!

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  • NicoleRod
    NicoleRod Member Posts: 2,906
    edited May 2020

    Yes... if I fail on the Doxil I just started we are going to apply for this.... has anyone spoken about side effects?

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  • BevJen
    BevJen Member Posts: 2,523
    edited May 2020

    Nicole (and interested others),

    This is from the NCI PDQ Updates for Professionals regarding this drug: definitely not the clearest of wording, but it has a few points here:

    Sacituzumab govitecan

    1. Sacituzumab govitecan is an antibody drug conjugate that combines an anti–trophoblast cell-surface antigen 2 antibody with an active metabolite of irinotecan.[102] In a phase I/II trial, 108 women with triple-negative breast cancer who had received at least two previous chemotherapy regimens (median, three) were treated with sacituzumab govitecan at a dose of 10 mg/kg intravenously on days 1 and 8 of a 21-day cycle.
      • A response rate of 33.3% (95% CI, 24.6%–43.1%) was observed.
      • The median duration of response was 7.7 months (95% CI, 4.9–10.8).[102][Level of evidence: 3iiiDiv]
      • The main toxicity was neutropenia, and four deaths occurred during treatment.
      • The FDA granted a breakthrough therapy designation for sacituzumab govitecan, and a confirmatory randomized trial is under way.
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