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May 8, 2018

Genentech secures FDA priority review status for Tecentriq

Genentech has secured priority review status from the US Food and Drug Administration (FDA) for the supplemental biologics licence application (sBLA) of lung cancer drug Tecentriq (atezolizumab).

Genentech has secured priority review status from the US Food and Drug Administration (FDA) for the supplemental biologics licence application (sBLA) of lung cancer drug Tecentriq (atezolizumab).

The sBLA seeks approval for Tecentriq in conjunction with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy) as first-line treatment for metastatic non-squamous non-small cell lung cancer (NSCLC) patients.

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq binds to PD-L1 expressed by tumour cells and tumour-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors.

Previously, the FDA approved the drug for metastatic NSCLC patients who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumour has certain gene abnormalities.

“The trial met the co-primary endpoints of overall survival (OS) and progression-free survival (PFS) during the initial treatment.”

Genentech included results from the Phase III clinical trial to support its sBLA. The multi-centre, open-label, randomised, controlled trial was conducted to assess the safety and efficacy of Tecentriq in combination with carboplatin and paclitaxel with or without Avastin.

In a total of 1,202 patients with stage IV non-squamous NSCLC, the trial met the co-primary endpoints of overall survival (OS) and progression-free survival (PFS) during the initial treatment.

The safety profile of the combination therapy was consistent with that of the individual medicines, without any new safety signals.

The trial examined key secondary endpoints such as investigator-assessed PFS and OS, safety in ITT population, as well as in EGFR and ALK mutation subgroups.

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