FDA approves first new treatment for common bladder cancer in 30 years
The FDA this week announced approval of Genentech's immunotherapy drug Tecentriq (atezolizumab) to treat advanced stages of the most common type of bladder cancer, called urothelial cancer.
Tecentriq is the first new treatment in more than 30 years for this type of cancer. The drug also expands a new class of molecularly targeted therapies called "checkpoint inhibitors," which remove immune system brakes that cancer exploits to evade attack. Tecentriq inhibits a braking pathway called PD-L1.
Given intravenously, Tecentriq is approved for patients with advanced or metastatic bladder cancer that has worsened despite standard chemotherapy. The key study of 310 patients that led to approval looked at the percentage of patients who experienced complete or partial shrinkage of their tumors, and whether the response varied based on the level of PD-L1 activity in the tumors.
Overall, almost 15 percent of patients saw at least partial tumor shrinkage for a period that lasted from about 2 months to more than 13.8 months. In patients with high PD-L1 activity, the response rate was better - 26 percent - and lasted a median of 12.7 months (meaning half the patients had shorter responses, and half had longer ones).
Because PD-L1 activity may help identify patients who are more likely to benefit from the drug, the FDA also approved a test, called Ventana PD-L1, to measure the activity level.
The most common side effects with Tecentriq were fatigue, loss of appetite, nausea, urinary tract infection, fever, and constipation. But the drug also can cause severe infections and organ problems because of the way it acts on the immune system.
Earlier this month, Robert Dreicer, a hematologist-oncologist at the University of Virginia Cancer Center, told Cure Today magazine that approval of Tecentriq could have a huge impact: "Given that bladder cancer is one of the last solid tumors that have a really amazingly unmet need, this will, overnight, change the management" of the disease.
About 77,000 new cases of bladder cancer -- of which 90 percent are urothelial -- will be diagnosed this year, and 16,400 people will die of the disease, the National Cancer Institute estimates.
Tecentriq is also currently under FDA priority review for patients with advanced lung cancer. Genentech, a division of Roche pharmaceuticals, expects a decision by October.
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