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    Association details:
    Biomarker:HR positive
    Cancer:HER2 Negative Breast Cancer
    Drug:samuraciclib (CT7001) (CDK7 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Carrick Therapeutics Press Release
    Title:

    CARRICK THERAPEUTICS RECEIVES FDA FAST TRACK DESIGNATIONS FOR TWO SAMURACICLIB COMBINATIONS FOR THE TREATMENT OF HR+, HER2- ADVANCED BREAST CANCER AND LOCALLY ADVANCED OR METASTATIC TRIPLE NEGATIVE BREAST CANCER

    Published date:
    08/16/2021
    Excerpt:
    Carrick Therapeutics...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designations to samuraciclib in combination with fulvestrant for CDK4/6i resistant HR+, HER2- advanced breast cancer and samuraciclib in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC).
    Secondary therapy:
    fulvestrant
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SABCS 2021
    Title:

    Study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in combination with fulvestrant in patients with advanced hormone receptor positive HER2 negative breast cancer (HR+BC)

    Published date:
    10/09/2021
    Excerpt:
    31 patients with HR+BC received the combination of standard dose with fulvestrant and samuraciclib...Samuraciclib has demonstrated an acceptable safety profile with evidence of anti-tumour activity in combination with fulvestrant for patients with advanced HR+BC who have progressed on their prior CDK4/6i.
    Secondary therapy:
    fulvestrant