The FDA has approved Genentech’s Tecentriq to treat urothelial carcinoma, the most common type of bladder cancer.
According to the agency, Tecentriq is the first FDA-approved PD-L1 inhibitor. It is approved for the treatment of patients whose condition has worsened during or following chemotherapy with platinum-containing products.
The drug showed at least a partial shrinkage of tumors in 14.8 percent of participants in a Phase 3 study, with the effect lasting from more than 2.1 to more than 13.8 months. Tecentriq was previously awarded breakthrough therapy designation, priority review status and accelerated approval.