Polivy is approved by MHLW in Japan to treat previously untreated diffuse large B-cell lymphoma (DLBCL).- Chugai/Roche
Chugai Pharmaceutical Co., Ltd. announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare for the anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy intravenous infusion 30 mg and 140 mg [generic name: polatuzumab vedotin (genetical recombination)] for an additional indication of treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL)
Polivy is an antibody-drug conjugate, which is a combination of an antibody and a small molecule compound. This approval is based on the global phase III clinical study (POLARIX study) in patients with previously untreated DLBCL. The study, which Japan participated in, is a phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of Polivy plus R-CHP versus R-CHOP. 879 patients were enrolled, and the primary endpoint was progression-free survival (PFS) as assessed by the investigator using the Lugano Response Criteria for malignant lymphom.
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