publication date: May. 20, 2016

Drugs and Targets

Accelerated Approvals Granted To Tecentriq and Opdivo 

 

FDA granted accelerated approval to Tecentriq (atezolizumab) for urothelial carcinoma, the most common type of bladder cancer. This is the first product in its class of PD-1/PD-L1 inhibitors approved to treat this type of cancer, according to the drug’s sponsor, Genentech.

Tecentriq is approved for the 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 surgical treatment.

The safety and efficacy of Tecentriq were studied in a single-arm phase II clinical trial involving 310 patients, and measured objective response rate. 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 all patients, 14.8 percent of participants experienced at least a partial shrinkage of their tumors, an effect that lasted from 2.1 to over 13.8 months at the time of the response analysis. In patients who were classified as positive for PD-L1 expression, 26 percent of participants experienced a tumor response, compared to 9.5 percent of participants who were classified as negative.

The FDA previously granted Tecentriq breakthrough therapy designation and priority review status.

FDA also approved the Ventana PD-L1 (SP142) Assay, developed by Roche, as a complementary diagnostic to provide PD-L1 status.

This test is the first to evaluate patient PD-L1 status … Continue reading 42-20 Accelerated Approvals Granted To Tecentriq and Opdivo

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