Therapy Areas: Respiratory
Roche's cancer immunotherapy TECENTRIQ (atezolizumab) granted FDA priority review for initial treatment of specific type of metastatic lung cancer
8 May 2018 -

Roche (SIX: RO, ROG; OTCQX: RHHBY) a Swiss multinational healthcare company, announced on Monday that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ(R) (atezolizumab), in combination with Avastin(R) (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC).

The FDA is expected to make a decision on approval by September 5 2018. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

This sBLA is based on results from the Phase III IMpower150 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with advanced non-squamous NSCLC.

Sandra Horning, MD, Roche's chief medical officer and head of Global Product Development, said: "Our phase III results showed TECENTRIQ in combination with Avastin, paclitaxel and carboplatin has the potential to provide a significant survival benefit in the initial treatment of metastatic non-squamous non-small cell lung cancer. We are working closely with the FDA to bring this treatment regimen to people with this type of lung cancer as soon as possible."