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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

Humanized Anti-CD20 Monoclonal Antibody Gazyva Approved for Additional Indication of Chronic Lymphocytic Leukemia

Published date:
12/23/2022
Excerpt:
Chugai Pharmaceutical Co., Ltd....and Nippon Shinyaku Co., Ltd....announced that Chugai obtained regulatory approval today from the Ministry of Health, Labour and Welfare (MHLW) for an anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva® Intravenous Infusion 1000 mg [generic name: obinutuzumab (genetical recombination)] for an additional indication of CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma)....The approval is based on data including the phase III ELEVATE-TN study...