Tecentriq is the first PD-L1 inhibitor approved by the FDA.
The U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) to treat urothelial carcinoma (UCC) [a.k.a Transitional cell carcinoma (TCC)], the most common type of bladder cancer. This is the first product in its class (PD-1/PD-L1 inhibitors) approved to treat this type of cancer.
Tecentriq targets the PD-L1 pathway. Targeting PD-L1 will block the interaction of PD-1 with PD-L1 (PD-1/PD-L1 pathway), which we also call checkpoint inhibitor pathway. By nature, checkpoint inhibitors are way to help the immune system not to attack the body's own cells. By blocking these interactions, Tecentriq may help activating body’s immune system to attack cancer cells. Tecentriq is the first FDA-approved PD-L1 inhibitor as well as the latest in the broader class of PD-1/PD-L1 targeted biologics approved by the FDA in the last two years.
Tecentriq targets the PD-L1 pathway. Targeting PD-L1 will block the interaction of PD-1 with PD-L1 (PD-1/PD-L1 pathway), which we also call checkpoint inhibitor pathway. By nature, checkpoint inhibitors are way to help the immune system not to attack the body's own cells. By blocking these interactions, Tecentriq may help activating body’s immune system to attack cancer cells. Tecentriq is the first FDA-approved PD-L1 inhibitor as well as the latest in the broader class of PD-1/PD-L1 targeted biologics approved by the FDA in the last two years.
For whom is Tecentriq: 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 (neoadjuvant) or after (adjuvant) surgical treatment.
What is urothlial carcinoma? Urothelial carcinoma is the most common type of bladder cancer and occurs in the urinary tract system, involving the bladder and related organs. The National Cancer Institute (NCI) estimates 76,960 new cases of bladder cancer and 16,390 deaths from the disease in 2016.
What is urothlial carcinoma? Urothelial carcinoma is the most common type of bladder cancer and occurs in the urinary tract system, involving the bladder and related organs. The National Cancer Institute (NCI) estimates 76,960 new cases of bladder cancer and 16,390 deaths from the disease in 2016.
The safety and efficacy of Tecentriq: The safety and efficacy of Tecentriq were studied in a single-arm clinical trial involving 310 patients with locally advanced or metastatic urothelial carcinoma. This trial measured the percentage of patients who experienced complete or partial shrinkage of their tumors (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 more than 2.1 to more than 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” for PD-L1 expression).
How to detect PD-L1 positive tumors: 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, 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.
Most common side effects of Tecentriq: The most common side effects of treatment with Tecentriq were fatigue, decreased appetite, nausea, urinary tract infection, fever (pyrexia) and constipation. Tecentriq also has the potential to cause infection and serious side effects that result from the immune system effect of Tecentriq (known as “immune-mediated side effects”). These severe immune-mediated side effects involve healthy organs, including the lung, colon and endocrine system.
Approval of Tecentriq: The FDA granted the Tecentriq application breakthrough therapy designation, priority review status and accelerated approval for this indication.
Who markets Tecentriq? Tecentriq is marketed by Genentech based in San Francisco, California. The Ventana PD-L1 (SP142) assay complementary diagnostic for Tecentriq is marketed by Ventana Medical Systems, based in Tucson, Arizona.
How to detect PD-L1 positive tumors: 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, 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.
Most common side effects of Tecentriq: The most common side effects of treatment with Tecentriq were fatigue, decreased appetite, nausea, urinary tract infection, fever (pyrexia) and constipation. Tecentriq also has the potential to cause infection and serious side effects that result from the immune system effect of Tecentriq (known as “immune-mediated side effects”). These severe immune-mediated side effects involve healthy organs, including the lung, colon and endocrine system.
Approval of Tecentriq: The FDA granted the Tecentriq application breakthrough therapy designation, priority review status and accelerated approval for this indication.
Who markets Tecentriq? Tecentriq is marketed by Genentech based in San Francisco, California. The Ventana PD-L1 (SP142) assay complementary diagnostic for Tecentriq is marketed by Ventana Medical Systems, based in Tucson, Arizona.
Source: The U.S. Food and Drug Administration (FDA)
