The approval pertains to patients who have locally advanced or metastatic urothelial carcinoma that progressed during or after platinum-based chemotherapy, or within 12 months of receiving either neoadjuvant or adjuvant platinum-based chemotherapy.
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.
By inhibiting PD-L1, tecentriq could allow the activation of T cells. It may also affect normal cells.
The indication for Tecentriq is approved under accelerated approval depending on tumor response rate and duration of response.
The accelerated approval follows breakthrough therapy designation and priority review status earlier granted by the FDA.
The rapid approval was based on results of the phase II open-label IMvigor 210 trial, which involved 310 patients with a primary endpoint of objective response rate (ORR).
The study also looked at the difference in effect based on positive versus negative expression of the PD-L1 protein on patients’ tumor-infiltrating immune cells.
In the entire study, 14.8 percent of participants experienced at least a partial shrinkage of their tumors. 26% of participants experienced a tumor response, compared to 9.5% of participants who were classified as "negative" for PD-L1 expression.
Fatigue, nausea, urinary tract infection, decreased appetite, fever (pyrexia) and constipation are the most common side effects of treatment with Tencentriq.