The FDA priority review is for Tecentriq in combination with chemotherapy comprising Avastin (bevacizumab), paclitaxel and carboplatin.
Roche said that its sBLA was filed on the basis of the data from the phase 3 trial dubbed IMpower150, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS).
The late-stage trial held in 1,202 people with advanced non-squamous NSCLC evaluated Tecentriq in combination with carboplatin and paclitaxel with or without Avastin. The participating patients were previously not treated with chemotherapy for their stage IV condition.
Roche chief medical officer and global product development head Sandra Horning 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.”
The FDA is likely to come up with its decision on approval of the Tecentriq plus chemotherapy combination by 5 September, 2018.
According to Roche, Tecentriq is a monoclonal antibody which inhibits the PD-L1 protein expressed on tumour cells and tumour-infiltrating immune cells.
Roche is carrying out eight phase 3 lung cancer trials to evaluate Tecentriq alone or in combination with other medicines.
The drug is already approved in the US, European Union, and more than 60 countries for people with previously treated metastatic NSCLC. It has also been approved for people with locally advanced or metastatic urothelial cancer (mUC) who cannot be treated with cisplatin chemotherapy, or whose condition advanced during or after platinum-containing therapy.
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