January 17, 2019 / 6:08 AM / 6 months ago

BRIEF-Roche Says FDA Accepts Its License Application For Tecentriq Plus Chemotherapy

Jan 17 (Reuters) - Roche Holding AG:

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

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

* SBLA IS BASED ON RESULTS FROM PHASE III IMPOWER130 STUDY, WHICH MET ITS CO-PRIMARY ENDPOINTS OF OVERALL SURVIVAL (OS) AND PROGRESSION-FREE SURVIVAL (PFS) IN INITIAL TREATMENT OF PEOPLE WITH METASTATIC NON-SQUAMOUS NSCLC Source text for Eikon: Further company coverage: (Reporting by Riham Alkousaa)

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