Roche tecentriq's application for first-line single drug treatment of lung cancer has won FDA's priority review

On February 19, Roche announced that American a has accepted tecentriq (atezolizumab) supplementary biological agent license application (SBLA), as a first-line (initial) single drug therapy, for PD-L1 high expression (TC3 / IC3 wild type [wt]) and no EGFR or ALK mutation in advanced non squamous and squamous non-small cell lung cancer (NSCLC) patients, determined by PD-L1 biomarker test The U.S FDA also grants the application priority review qualification, and will make the approval decision before June 19, 2020 Last week, tecentriq was just approved for marketing in China (atelizumab, trade name is taishengqi) to combine chemotherapy for the first-line treatment of a wide range of small cell lung cancer This SBLA is based on the results of 3-phase clinical study impower110, which showed that in the population with high PD-L1 expression (TC3 / ic3-wt), tecentriq single drug treatment prolonged the total survival (OS) by 7.1 months compared with chemotherapy (median OS = 20.2 vs 13.1 months; risk ratio [HR] = 0.595, 95% CI: 0.398-0.890; P = 0.0106) The security of tecentriq is consistent with its known security features, and no new security signal is found 12.9% of tecentriq patients and 44.1% of chemotherapy patients reported treatment-related adverse events (AE) "In the impower 110 study, tecentriq monotherapy demonstrated a significant improvement in overall survival compared to chemotherapy in newly diagnosed patients with certain types of advanced non-small cell lung cancer," said Levi, Roche Global Head of product development and chief medical officer "We are working closely with the FDA to bring chemotherapy free treatment options to these lung cancer patients as soon as possible," Dr Garraway said At present, tecentriq's lung cancer research program includes nine phase 3 lung cancer studies, including single drug therapy and combination therapy, to treat different types of lung cancer In addition, Roche has developed a wide range of development plans for tecentriq, including a number of ongoing and planned phase 3 studies involving lung, urogenital system, skin, breast cancer, gastrointestinal tract, gynecology and head and neck cancer reference material: [1] FDA grants priority review to Roche’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer Retrieved 2020-02-19, from https:// Original title: A kind of