FDA extends review period of Tecentriq + Avastin + chemo to treat non-squamous NSCLC to 5 December 2018.- Genentech/Roche

Roche has been notified by the FDA that the review period for the supplemental Biologics License Application (sBLA) for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab), carboplatin and paclitaxel for the initial treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) has been extended by three months. The extension allows the FDA time to review additional information requested in support of the sBLA.

FDA determined that the submission of this information constituted a major amendment to the sBLA resulting in this extension of the PDUFA goal date. The FDA is expected to make a decision on approval by 5 December 2018. In May 2018, Tecentriq in combination with Avastin, carboplatin and paclitaxel was granted Priority Review from the FDA for the initial treatment of people with metastatic non-squamous NSCLC based on results from the Phase III IMpower150 study.