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Roche’s Tecentriq bags Priority Review in US

Roche’s Tecentriq bags Priority Review in US

The US Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application (sBLA), granting Priority Review for Tecentriq (atezolizumab) for certain patients with non-small cell lung cancer (NSCLC).

The monoclonal antibody has been granted the review as a first-line (initial) monotherapy for people with advanced non-squamous and squamous variations of NSCLC, for patients without EGFR or ALK mutations with high PD-L1 expression.

Roche says that the decision was based on the IMpower110 study, in which Tecentriq alone “demonstrated a significant improvement in overall survival compared with chemotherapy for people newly diagnosed with certain types of advanced non-small cell lung cancer,” according to Levi Garraway, chief medical officer and head of global product development.

In the trial, the drug improved overall survival (OS) by 7.1 months compared with chemotherapy, and safety appeared to be consistent with its known safety profile, with no new safety signals identified.

“We are working closely with the FDA to bring this chemotherapy-free option to these patients as quickly as possible.”

Lung cancer is the leading cause of cancer death globally. Each year 1.76 million people die as a result of the disease; a number that translates into more than 4,800 deaths worldwide every day.

NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.

20th February 2020

http://www.pharmatimes.com/

February 20, 2020 / Pharma News
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