FDA Grants Tecentriq Priority Review for NSCLC

The FDA is expected to make a decision on this indication by December 1, 2021.

The FDA has granted priority review for Roche’s Tecentriq (atezolizumab) as an adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumors express PD-L1.

Tecentriq is approved in the United States, European Union, and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, small cell lung cancer (SCLC), certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma.

In the United States, Tecentriq is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for BRAF V600 mutation-positive advanced melanoma.

The FDA is reviewing Roche’s supplemental Biologics License Application (sBLA) application and is expected to make a decision on approval by December 1, 2021, Roche said in a statement.

This application is based on disease-free survival (DFS) results from an interim analysis of the phase 3 IMpower010 study. This study showed that treatment with Tecentriq, following surgery and platinum-based chemotherapy, reduced the risk of disease recurrence or death by 34%. Results were presented at the 2021 American Society of Clinical Oncology Annual Meeting.

Roche plans to continue to follow up on the IMpower010 trial with planned analyses of DFS in the overall intent-to-treat (ITT) population, including Stage IB patients, which at the time of analysis did not cross the threshold, and overall survival (OS) data, which were immature at the time of interim analysis. Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified.

“New treatment options are urgently needed in early-stage non-small cell lung cancer to help the nearly 50% of people who currently experience a recurrence following surgery,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Roche. “Tecentriq is the first cancer immunotherapy to show a clinically meaningful benefit in the adjuvant lung cancer setting, and we’re working closely with the FDA to bring this significant advancement to patients as quickly as possible.”