FDA accepts Genetec's application for license to supplementary biologics for Tecentriq

lung cancer is the highest incidence and mortality rate in China, including NSCLC accounts for about 80% to 85% of the overall proportion of lung cancertoday (January 18), Roche's Genentechcompany,(http://announced that the u.SFDA(http://had accepted the company's supplementary biology for Tecentriq Preparation license application (sBLA) is used in combination with chemotherapy (caplatinum and albumin-binding yew alcohol) as a first-line therapy for metastatic non-squamous non-small cell lung cancer (NSCLC) that does not carry eGFR/ALK gene mutationsthe application is expected to be approved by September 2, 2019the heavy immuno
drug(http://) of tecentriqgene, tecentriq is a PD-L1 monodepin that binds to PD-L1 on tumor cells and tumor-immersed immune cells, blocking its action with PD-1 and B7.1 receptors, thereby reactivating T cells and killing cancer cellspreviously, in December 2018, the FDA approved a combination of tecentriq and avastin, yew alcohol and caplatinum as a first-line treatment for patients with metastatic non-scaly NSCLC who do not carry mutations in the EGFR/ALK geneIn addition, Tecentriq has been approved as a second-line therapy for patients with metastatic NSCLCThe application for iMpower130this sBLA is based on the results of a 3-phaseTest(http://IMpower130The IMpower130 trial was designed to assess the effectiveness and safety of tecentriq combination therapy made up of caplatinum and albumin-combined yew alcohol, which were effective and safe in patients with phase IV non-scale NSCLC initial treatment compared to the use of chemotherapy alone (caplatinum and albumin-combined yew alcohol)724 patients were randomly treated with Tecentriq caplatinum and albumin-combined yew alcohol (group A), or caplatinum and albumin-combined yew alcohol (group B, control group) on a 2:1 scalethe study reached its common primary endpoint: the mid-stage trial results showed that tecentriq plus chemotherapy combination therapy not only significantly improved the overall survival of patients (18.6 months in median OS and 13.9 months in the control group) compared to the control group using chemotherapy alone, but also significantly reduced the risk of disease progression and death in patients (median PFS was 7.0 months and the control group was 5.5 months)the safety of the combination therapy is consistent with the known safety of individual drugs, no new safety issues have been identified