January 17, 2019 / 6:09 AM / a month ago

BRIEF-FDA Accepts Genentech's Supplemental Biologics License Application For Tecentriq Plus Chemotherapy

Jan 17 (Reuters) - Roche Holding AG:

* FDA ACCEPTS GENENTECH’S SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR TECENTRIQ PLUS CHEMOTHERAPY (ABRAXANE AND CARBOPLATIN) FOR THE INITIAL TREATMENT OF METASTATIC NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

* FDA IS EXPECTED TO MAKE A DECISION ON APPROVAL BY SEPTEMBER 2, 2019

* SBLA IS BASED ON RESULTS FROM PHASE III IMPOWER130 STUDY, WHICH MET ITS CO-PRIMARY ENDPOINTS Source text for Eikon: Further company coverage:

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