30 August 2019 - Genentech was notified by the U.S. FDA that the review period for the supplemental biologics license application for Tecentriq (atezolizumab) in combination with Abraxane (albumin-bound paclitaxel; nab-paclitaxel) and carboplatin for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer who do not have EGFR or ALK genomic tumour aberrations has been extended by three months.
The extension allows the FDA time to review additional information requested in support of the application. The FDA is expected to make a decision on approval by 2 December 2019.
In January 2019, the FDA accepted this application based on results from the Phase III IMpower130 study.