Posted by Michael Wonder on 03 Aug 2021
US FDA grants priority review to Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
3 August 2021 - Application is being reviewed under the US FDA’s Real-Time Oncology Review pilot programme.
Roche today announced that the US FDA has accepted the company’s supplemental biologics license application and granted priority review for Tecentriq (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer whose tumours express PD-L1≥1%, as determined by an FDA approved test.
The FDA is expected to make a decision on approval by 1 December 2021.
