• FDA approves Keytruda for patients with previously treated hepatocellular carcinoma

    6 monthes ago - By Healio

    The FDA granted accelerated approval to pembrolizumab for the treatment of patients with hepatocellular carcinoma who received prior sorafenib.
    The approval is the 14th indication for pembrolizumab , an anti-PD-1 therapy.
    The FDA based the approval on results of the single-arm, open-label KEYNOTE-224 trial. The trial included 104 patients (median age, 68 years; 83% male; 81% white; 14% Asian) with HCC who experienced disease progression during or after sorafenib treatment or were intolerant to sorafenib.
    All patients had ECOG performance status of 0 or 1
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