TOKYO - Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has obtained regulatory approval for its humanized anti-PD-L1 monoclonal antibody, Tecentriq [generic name: atezolizumab (genetical recombination)] from the Ministry of Health, Labour and Welfare (MHLW) for an additional indication of PD-L1-positive, hormone receptor-negative and HER2-negative inoperable or metastatic breast cancer.
It has also obtained approval for an additional formulation of Tecentriq 840 mg. Tecentriq 840 mg was developed to provide an optimal formulation for breast cancer for which approved dosage is 840 mg once every 2 weeks.
VENTANA OptiView PD-L1 (SP142), a pathological testing kit marketed by Roche Diagnostics K.K., should be used to detect PD-L1 expression. An expanded use of VENTANA OptiView PD-L1 (SP142) as a companion diagnostic of Tecentriq was approved on August 20, 2019 to allow physicians to identify patients with PD-L1-positive breast cancer who could benefit from Tecentriq.
'We are very pleased that Tecentriq has been approved as the first immune checkpoint inhibitor for the treatment of PD-L1-positive triple-negative breast cancer (TNBC) in Japan,' said Dr. Yasushi Ito, Chugai's Executive Vice President, Co-Head of Project & Lifecycle Management Unit. 'This approval provides a novel cancer immunotherapy-based treatment for TNBC, a rapidly-progressing cancer with limited therapeutic options. We are committed to contribute to patients through the treatment.'
This approval is based on the results from the phase III IMpassion130 study. Tecentriq in combination with nab-paclitaxel (albumin-bound) met primary endpoint with a significant reduction in the risk of disease worsening or death (PFS) compared with nab-paclitaxel (albumin-bound) alone in the intention-to-treat (ITT) population (median PFS=7.2 vs 5.5 months; hazard ratio [HR]=0.80, 95%CI: 0.69-0.92, p=0.0025) and in people who were tested positive for PD-L1 expression (median PFS=7.5 vs 5 months; hazard ratio [HR]=0.62, 95% CI: 0.49-0.78, p
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