Genentech has had its supplemental Biologics License Application rubber-stamped by the US FDA for the first-line treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC).
The FDA has also granted Tecentriq Priority Review with a decision expected by September.
“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, 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.”
This approval is based on results from the Phase III IMpower150 study, which met its co-primary endpoints of overall survival and progression-free survival in the initial treatment of people with advanced non-squamous NSCLC.
The safety profile of the combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified.
Tecentriq is currently approved 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 or EGFR gene abnormalities.