Roche’s (RHHBY.OB) Tecentriq, which in combination with Paclitaxel protein-bound, secured accelerated approval from the FDA, in March 2019, for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer, is scheduled to be reviewed by an FDA panel on April 27, 2021.The accelerated approval was given based on data from a phase III study, dubbed IMpassion130, which demonstrated that Tecentriq plus Paclitaxel protein-bound significantly reduced the risk of disease worsening or death (PFS) by 40 percent compared with Paclitaxel protein-bound alone.However, in a confirmatory phase III trial, named IMpassion131, whose results were reported last August, the combination of Tecentriq and Paclitaxel protein-bound did not meet statistical significance on its primary endpoint of progression-free survival.Since Tecentriq for the above-mentioned indication has failed in a confirmatory trial, a meeting of outside experts has been convened by the FDA to weigh in the option – i.e., whether or not to remove this particular indication from the drug’s label.RHHY.OB closed Friday’s (Mar.26, 2021) trading at $40.45, down 0.49%.