FDA approves atezolizumab for metastatic bladder cancer

The U.S. FDA has approved immunotherapy based treatment for metastatic bladder cancer which will improve body’s immune system to fight against cancer. Bladder cancer is the fourth-most common cancer among men in the United States. Each year, 77,000 adults are diagnosed with bladder cancer in the United States as per American Cancer Society data.

Atezolizumab (Tecentriq, Genentech, Inc.) works by improving the immune system to fight cancer. The treatment is the first new treatment to be approved for bladder cancer in the last three decades. Atezolizumab acts as a programmed cell death ligand inhibitor (PD-L1).

After checking results of Mvigor 210 trial, an open-label, multicenter, phase 2 trial, FDA panel gave approval to atezolizumab immunotherapy treatment. The study involved 310 patients with locally advanced or metastatic urothelial carcinoma. The results showcased that median progression-free survival was 2.1 months for all patients. The median overall survival was 7.9 months for all patients. For the highest-positivity subgroup, the survival time was 11.4 months and for lowest-positivity group, survival was 6.7 months.

“Atezolizumab provides these patients with a new therapy targeting the PD-L1 pathway,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Genentech aims to introduce the drug in the U.S. market in 1-2 weeks.

The FDA release informed….

Tecentriq targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). By blocking these interactions, Tecentriq may help the body’s immune system fight cancer cells. Tecentriq is the first FDA-approved PD-L1 inhibitor and the latest in the broader class of PD-1/PD-L1 targeted biologics approved by the FDA in the last two years.

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. 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 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).

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.

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.

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