US regulators are undertaking a priority review of Roche unit Genentech’s PD-L1 inhibitor Tecentriq, in combination with Avastin and standard chemotherapy for some patients with lung cancer.
The application is seeking permission to market the combination for the first-line treatment of patients with metastatic non-squamous non-small-cell lung cancer (NSCLC).
The submission is based on data from the Phase III IMpower150 trial, which showed that Tecentriq (atezolizumab)/Avastin (bevacizumab) and chemotherapy significantly prolonged overall survival and progression-free survival versus Avastin and chemotherapy alone.
“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,” said Sandra Horning, Roche’s chief medical officer and head of Global Product Development.
“We are working closely with the FDA to bring this treatment regimen to people with this type of lung cancer as soon as possible.”
The monoclonal antibody is currently cleared by the FDA to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumour has ALK and EGFR mutations.
A decision on its first-line use is expected by September 5.