FDA approval of a new form of immunotherapy as well as a companion diagnostic test will have a significant impact on patients with the most common type of bladder cancer in the U.S., a leading urologic cancer expert says.
In May, the FDA approved atezolizumab (TECENTRIQ) for treatment of locally advanced or metastatic urothelial carcinoma (mUC) that has progressed during or following platinum-based chemotherapy, or has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.
The FDA also approved VENTANA PD-L1 (SP142) Assay (developed by Roche and available through LabCorp) as a complementary diagnostic for atezolizumab. The assay measures PD-L1 expression in the bladder cancer tissue and has an immune cell scoring algorithm that can help urologists and others identify potentially good candidates for atezolizumab treatment.
Atezolizumab, the first and only anti-PD-L1 cancer immunotherapy approved by the FDA, was granted an accelerated, or conditional, approval because it helps to fill an unmet need. The drug is the first FDA-approved treatment for people with this specific type of bladder cancer in more than 3 decades, according to a press release from Genentech.