Roche's Tecentriq As Adjuvant Treatment Under Priority Review With FDA For Early Lung Cancer

The FDA has granted priority review for Genentech's, a unit of Roche Holdings AG RHHBY Tecentriq (atezolizumab), as adjuvant treatment for certain patients with early non-small cell lung cancer.
The application covers patients following surgery and platinum-based chemotherapy with non-small cell lung cancer whose tumors express PD-L1≥1%.
The application is based on disease-free survival results from an interim analysis of Phase 3 IMpower010 study.
The study showed that treatment with Tecentriq reduced the risk of disease recurrence or death (DFS) by 34%, compared with best supportive care (BSC).
In this population, median DFS was not yet reached for Tecentriq compared with 35.3 months for BSC.
The FDA is reviewing the application under the Real-Time Oncology Review pilot program and is anticipated to decide on approval by December 1.
Price Action: RHHBY shares closed at $48.54 on Monday.
Related content: Benzinga's Full FDA Calendar.