Genentech, a member of the Roche Group, announced that the FDA has accepted the company's supplemental Biologics License Application, or sBLA, and granted Priority Review for Tecentriq as a first-line monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer, or 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. Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
Citi analyst Andrew Baum upgraded Roche to Buy from Neutral with a CHF 395 price target. The company's pipeline, especially tiragolumab and Alzheimer drug gantenerumab, is being underappreciated at current share levels, Baum tells investors in a research note. The analyst believes Roche's decision to start phase 3 tiragolumab trials in five indications shows confidence based on the 500-patient trial.