Benzinga | Aug 3, 2021 06:32AM EDT

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 (OTC: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.