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    Association details:
    Biomarker:No biomarker
    Cancer:Cervical Cancer
    Drug:Libtayo (cemiplimab-rwlc) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Regeneron Pharmaceuticals Press Release
    Title:

    LIBTAYO® (CEMIPLIMAB) APPROVED IN JAPAN FOR ADVANCED OR RECURRENT CERVICAL CANCER

    Published date:
    12/23/2022
    Excerpt:
    Regeneron Pharmaceuticals (NASDAQ: REGN) today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Libtayo® (cemiplimab) as monotherapy to treat patients with advanced or recurrent cervical cancer whose disease progressed after chemotherapy.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Regeneron Pharmaceuticals Press Release
    Title:

    LIBTAYO® (CEMIPLIMAB) APPROVED BY THE EUROPEAN COMMISSION AS THE FIRST IMMUNOTHERAPY IN SECOND LINE RECURRENT OR METASTATIC CERVICAL CANCER IRRESPECTIVE OF PD-L1 EXPRESSION LEVEL OR TUMOR HISTOLOGY

    Published date:
    11/22/2022
    Excerpt:
    Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) approved Libtayo® (cemiplimab) as monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy....Approval based on a Phase 3 trial that demonstrated significant survival benefit in patients with recurrent or metastatic cervical cancer, with Libtayo reducing the risk of death by 31% compared to chemotherapy during the study.
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NCCN
    Published date:
    09/20/2023
    Excerpt:
    Cervical Cancer: SYSTEMIC THERAPY FOR CERVICAL CANCER…Preferred Regimens…Cemiplimab…