Roche's Tecentriq immuno-oncology drug failed a late-stage follow-up trial against advanced bladder cancer, as the drugmaker awaits full-approval from regulators.
Roche was granted fast-track approval last May for Tecentriq against bladder cancer, but the FDA’s full approval hinged on further trials.
Roche announced that its phase III study of Tecentriq in people with previously treated advanced bladder cancer did not meet its primary endpoint of overall survival compared to chemotherapy.
“While these results are not what we had expected, we believe that Tecentriq will continue to play an important role in the treatment of people with advanced bladder cancer,” said Sandra Horning, M.D., chief medical officer and Head of Global Product Development. “We are committed to helping people with advanced bladder cancer and will discuss these data with health authorities.”
Read the press release