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USFDA approved Tecentriq

26-May-2016

The United States Food and Drug Administration (USFDA) has approved Tecentriq (Atezolizumab) for the treatment of urothelial carcinoma. Tecentriq is the first PD-1/PD-L1 inhibitor that has been approved for urothelial carcinoma. Tecentriq is indicated for advanced or metastatic urothelial carcinoma patients who are unresponsive to platinum-based chemotherapy or worsening of disease after surgical treatment.

 

Tecentriq targets the PD-L1 pathway and interrupts the synthesis of metabolites of PD-1/PD-L1 pathway. Blocking the pathway could aid the body’s immune cells to combat malignant cells.

 

Tecentriq has been approved with breakthrough designation after priority review and accelerated approval process.

 

Single-arm clinical trial involving 310 subjects has been conducted to demonstrate the safety and efficacy of Tecentriq. The outcomes measure of the study was percentage of partial or complete shrinkage of tumors which was considered as objective response rate and endpoint of the study. The same has been achieved by the treatment cohort.

 

Some of the common reported adverse events of Tecentriq were anorexia, urinary tract infection, fever, GI disturbances including constipation and fatigue. Other serious adverse events include immune-mediated adverse events were also reported.

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