The news is a sign that U.S. approval of the Swiss drugmaker's
immunotherapy may not go as smoothly as hoped.
Roche is hoping to clinch more of the lung cancer treatment market
with its Tecentriq immunotherapy, but suffered a setback in July
when a trial failed to deliver survival data it needs to challenge
"The extension allows the FDA time to review additional information
requested in support of the supplemental Biologics License
Application", Roche said in a statement.
It said the FDA was expected to make a decision on the approval by
Tecentriq -- also known as atezolizumab -- in combination with
Avastin, carboplatin and paclitaxel was granted priority review from
the FDA in May for the initial treatment of people with metastatic
non-squamous non-small cell lung cancer (NSCLC).
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It is already approved in the European Union, United States and more
than 70 countries for people with previously treated metastatic
NSCLC and for certain types of untreated or previously treated
metastatic urothelial carcinoma.
Roche said in a separate release on Thursday that it would present
new data from its Tecentriq lung cancer program at a conference this
Roche shares were set to open 0.7 percent lower, according to
pre-market indications by bank Julius Baer.
(Reporting by Silke Koltrowitz; Editing by Maria Sheahan and Michael
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