Posted by Michael Wonder on 07 May 2018
FDA grants priority review to Roche’s cancer immunotherapy Tecentriq (atezolizumab) for initial treatment of people with a specific type of metastatic lung cancer
7 May 2018 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application and granted priority review for Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small-cell lung cancer.
The FDA is expected to make a decision on approval by 5 September 2018.
This application is based on results from the Phase III IMpower150 study, which met its co-primary endpoints of overall survival and progression-free survival in the initial treatment of people with advanced non-squamous non-small-cell lung cancer. The safety profile of the combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified.
