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Genentech: Tecentriq With Chemotherapy Gets FDA Priority Review For ES-SCLC

Genentech, a member of the Roche Group (RHHBY), announced Wednesday that the U.S. Food and Drug Administration or FDA has granted priority review to Tecentriq in combination with Chemotherapy for the initial treatment of extensive-stage small cell lung cancer or ES-SCLC.

The FDA has accepted the company's supplemental Biologics License Application or sBLA . The FDA is expected to make a decision on approval by March 18, 2019. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease.

This sBLA is based on results from the Phase III IMpower133 study, which met its co-primary endpoints of overall survival and progression-free survival in the initial treatment of people with ES-SCLC.

Tecentriq is currently approved by the FDA to treat people with metastatic non-small cell lung cancer or NSCLC who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has ALK or EGFR gene abnormalities.

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