The drug was approved for use in 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 approval comes following a clinical trial, which was completed on 310 patients with locally advanced or metastatic urothelial carcinoma. Nearly 15 percent of patients saw shrinkage in their tumor lasting for at least two months and up to 14 months.
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.
Common side effects of Tecentriq were fatigue, decreased appetite, nausea, urinary tract infection, fever, and constipation. Some side effects may affect healthy organs like the lungs or heart, concluded the FDA.
Also, read Bel Marra Health’s article on 3 signs you may have a bladder problem.