Tecentriq obtains regulatory approval from MHLW as the first immunotherapy in Japan for adjuvant treatment of non-small cell lung cancer.- Chugai
Chugai Pharmaceutical Co., Ltd. announced that it obtained regulatory approval for an additional indication of the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)] for the adjuvant treatment of PD-L1-positive non-small cell lung cancer (NSCLC) from the Ministry of Health, Labour and Welfare.
VENTANA OptiView PD-L1 (SP263), a pathological testing kit marketed by Roche Diagnostics K.K., should be used to detect PD-L1 expression. An expanded use of this test kit as a companion diagnostic for Tecentriq was approved on May 23, 2022 to allow physicians to identify patients with PD-L1-positive NSCLC who could benefit from Tecentriq.
This approval is based on the results from phase III IMpower010 study examining Tecentriq as an adjuvant treatment in NSCLC. The study showed that treatment with Tecentriq following surgery and chemotherapy reduced the risk of disease recurrence or death (disease-free survival; DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) in people with Stage II-IIIA NSCLC, whose tumors express PD-L1?1%, compared with best supportive care (BSC). The most frequent adverse reactions (5% or more) included hypothyroidism, pruritus, rash, increased AST, increased ALT, hyperthyroidism, pyrexia, and arthralgia.
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