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Atezolizumab (Tecentriq™) Receives FDA Approval for Bladder Cancer

May 19, 2016

A day after the FDA approved the use of one anti-PD-1 checkpoint inhibitor for advanced Hodgkin lymphoma, the agency approved another―Genentech’s atezolizumab (Tecentriq™), a PD-L1 antibody―to treat a type of advanced bladder cancer.

“These results…represent the first major treatment advancement in advanced bladder cancer in nearly 30 years,” said Sandra Horning, M.D., chief medical officer and head of global product development at Genentech.

Until yesterday, patients with metastatic urothelial carcinomas had no other approved treatment options if chemotherapy failed. Shirley Dumont was one of those patients. Having already had cancer in her breast, ovary, and kidney, she then developed bladder cancer that spread to her lungs. Fortunately, she decided to enroll in the phase II IMvigor 210 study, and now, more bladder cancer patients may be able to benefit just like Shirley.


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“Even though bladder cancer is the fifth most commonly diagnosed cancer in the United States, it hasn’t received the same attention within the cancer community as other common cancers,” said Diane Zipursky Quale, the president and co-founder of the Bladder Cancer Advocacy Network.

The FDA approved atezolizumab through its Accelerated Approval Program as a drug that fulfills an unmet clinical need based on early results from the phase II trial that indicated the drug provided patients a clinical benefit. Traditionally, most investigational therapies must proceed through large phase III clinical trials before approval.

Atezolizumab is the first checkpoint inhibitor available for bladder cancer, and CRI played a prominent role in the development of PD-1/PD-L1 immunotherapies, funding the basic research that discovered the PD-1 pathway. These scientists received the William B. Coley Award in 2014 for their contributions to this immunotherapy breakthrough.

This anti-PD-L1 checkpoint inhibitor is also the second immunotherapy overall approved for bladder cancer patients. The other is a vaccine called bacillus Calmette-Guérin (BCG), initially intended as a treatment for tuberculosis. The BCG vaccine, like the anti-PD-L1 atezolizumab, works by stimulating a stronger immune response against bladder cancer cells, and leads to remission in approximately 70% of patients.

CRI also contributed to the development of BCG immunotherapy. In 1959, Lloyd J. Old, M.D., our founding medical and scientific director, led the team that first showed that BCG could inhibit tumor growth in mice. Later, CRI funded the work of Alvaro Morales, M.D., FRCSC, FACS, who demonstrated BCG’s effectiveness in preventing recurrence of bladder cancer, which led to its FDA approval in 1990. For this, Dr. Morales also received the William B. Coley Award in 1993.

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