While patients who received Tecentriq experienced a tumor response across the study, the greater effect in those who were classified as "positive" for PD-L1 expression suggests that the level of PD-L1 expression in tumor-infiltrating immune cells may help identify patients who are more likely to respond to treatment with Tecentriq. Therefore, today the FDA also approved the Ventana PD-L1 (SP142) assay to detect PD-L1 protein expression levels on patients' tumor-infiltrating immune cells and help physicians determine which patients may benefit most from treatment with Tecentriq.
The most common side effects of treatment with Tencentriq were fatigue, decreased appetite, nausea, urinary tract infection, fever (pyrexia) and constipation. Tencentriq also has the potential to cause infection and serious side effects that result from the immune system effect of Tencentriq (known as "immune-mediated side effects"). These severe immune-mediated side effects involve healthy organs, including the lung, colon and endocrine system.
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The FDA granted the Tecentriq application breakthrough therapy designation, priority review status and accelerated approval for this indication. These are distinct programs intended to facilitate and expedite the development and review of certain new drugs in light of their potential to benefit patients with serious or life-threatening conditions.
Tecentriq is marketed by Genentech based in San Francisco, California. The Ventana PD-L1 (SP142) assay companion diagnostic for Tecentriq is marketed by Ventana Medical Systems, based in Tucson, Arizona.
For more information:
FDA: Office of Hematology and Oncology Products
FDA: Approved Drugs: Questions and Answers
FDA: Companion Diagnostics
NCI: Bladder Cancer
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
SOURCE U.S. Food and Drug Administration
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