FDA Grants Priority Review to Genentech´s Tecentriq Monotherapy as First-Line Treatment of Certain People With Advanced Non-Small Cell Lung Cancer
(WorldNews Health)

Tuesday, Feb 18, 2020 South San Francisco, CA -- February 18, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company`s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type [WT]), as determined by PD-L1 biomarker testing. The FDA is expected to make a decision on approval by June 19, 2020. `In the IMpower110 study, Tecentriq alone...