FDA also approves a companion test to detect PD-L1 protein expression levels in patients
THURSDAY, May 19, 2016 (HealthDay News) — The U.S. Food and Drug Administration has approved atezolizumab (Tecentriq), a PD-1/PD-L1 inhibitor, for treatment of patients with locally-advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before or after surgery.
The FDA’s approval of Tecentriq is based on a clinical trial involving 310 patients with locally-advanced or metastatic urothelial carcinoma. Nearly 15 percent of patients had at least partial shrinkage of their tumors, which lasted from about two months to nearly 14 months at the time the data was analyzed. Tumor response occurred in 26 percent of patients who were positive for PD-L1 expression, compared with 9.5 percent of those who were negative for PD-L1 expression.
During the clinical trial, common side effects associated with Tecentriq were fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, and constipation. The drug also has the potential to cause infection and serious immune system side effects involving healthy organs such as the lungs, colon, and endocrine system, the FDA said.
The FDA also approved a companion test to detect PD-L1 protein expression levels in patients, to help doctors identify those most likely to benefit from Tecentriq.
Tecentriq is made by San Francisco-based Genentech.
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