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December 6, 2018

Roche’s Tecentriq gets FDA priority review to treat small cell lung cancer

The US Food and Drug Administration (FDA) has granted priority review for Roche’s Tecentriq (atezolizumab) in combination with chemotherapy for treating extensive-stage small cell lung cancer (ES - SCLC).

The US Food and Drug Administration (FDA) has granted priority review for Roche’s Tecentriq (atezolizumab) in combination with chemotherapy for treating extensive-stage small cell lung cancer (ES – SCLC).

The supplemental Biologics License Application (sBLA) submitted by the company for Tecentriq is based on results from its Phase III IMpower133 study.

According to Roche, the multi-centre, double-blinded, randomised placebo-controlled study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with ES-SCLC.

The FDA is expected to make its final decision on approval by 18 March next year.

Roche Global Product Development head and chief medical officer Sandra Horning said: “It’s been more than 20 years since there has been a new initial treatment option for extensive-stage small cell lung cancer that delivers a clinically meaningful survival benefit.

“We are working closely with the FDA to bring this Tecentriq-based regimen to people with this difficult-to-treat type of lung cancer as soon as possible.”

“We are working closely with the FDA to bring this Tecentriq-based regimen to people with this difficult-to-treat type of lung cancer as soon as possible.”

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Currently, Tecentriq is approved in the US to treat patients with metastatic non-small cell lung cancer (NSCLC) showing disease progression during or following platinum-containing chemotherapy.

It can also be used to treat patients who have progressed on an appropriate FDA-approved targeted therapy if their tumour has ALK or EGFR gene abnormalities.

A monoclonal antibody, Tecentriq is developed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells preventing interactions with PD-1 and B7.1 receptors.

According to the company, Tecentriq can be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies to treat various forms of cancers.

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