Roche's Genentech unit on Thursday announced that the FDA cleared Tecentriq (atezolizumab) in combination with Avastin (bevacizumab), carboplatin and paclitaxel for the first-line treatment of patients with metastatic non-squamous non-small-cell lung cancer who lack GFR or ALK genomic tumour aberrations. Roche chief medical officer Sandra Horning commented "this Tecentriq regimen has demonstrated a significant survival benefit in the initial treatment of metastatic non-squamous non-small cell lung cancer."
The approval was based on data from the Phase III IMpower150 trial, with results from the study reported last year showing that the combination regimen significantly delayed the time until disease worsening or death versus Avastin plus chemotherapy, while later data disclosed in March illustrated that the treatment significantly prolonged overall survival.
The approval comes after the FDA extended its review of the regimen by three months in September to permit the analysis of additional information. The agency previously granted priority review to Roche's filing of the regimen in May.
Tecentriq has been authorised in the US for use in certain patients with previously treated metastatic NSCLC and locally advanced or metastatic urothelial cancer. The PD-L1 inhibitor was awarded priority review last month in combination with chemotherapy for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer in PD-L1-positive patients.
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