Friday, June 14, 2013

Avastin receives Japan approval for treatment of recurrent malignant glioma

Chugai Pharmaceutical Co., Ltd. has obtained approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional indication and dosage and administration of “Malignant glioma,” for the anti-cancer agent / anti-VEGF humanized monoclonal antibody, "AVASTIN® I.V. Infusion 100mg/4mL and 400mg/16m.
This approval was obtained based on the data of the US phase II clinical study (The BRAIN study) in patients with glioblastoma that recurred after treatment with temozolomide and radiotherapy, the Japanese phase II clinical study (JO22506 study) in which a single agent of Avastin® was administered in patients with recurrent malignant glioma, and the phase III global, randomized, placebo-controlled comparative study (The AVAglio study) in which Avastin® was combined with standard radiotherapy and temozolomide in patients with newly diagnosed glioblastoma. The BRAIN study demonstrated a progression-free survival at 6 months of 42.6% and an objective response rate of 28.2%. The JO22506 study demonstrated a progression free survival at 6 months of 33.9% and an objective response rate of 27.6% in patients with glioblastoma. These efficacy data exceed those reported in the previous studies with recurrent glioblastoma patients.

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