FDA Approves Genentech’s Bladder Cancer Treatment

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.