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Roche’s Immunotherapy Drug Wins FDA Approval

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FDA

The therapy – branded by Roche as Tecentriq – won early US Food and Drug Administration (FDA) approval this week.

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May 20, 2016 | by Sarah Massey, M.Sc.

Roche’s anti-PDL1 immunotherapy, atezolizumab, has become the first new drug in decades to be approved to treat the most common form of bladder cancer. The therapy – branded by Roche as Tecentriq – won early US Food and Drug Administration (FDA) approval this week.

Tecentriq joins Bristol-Myers Squibb's Opdivo and Merck's Keytruda as the only anti-PD1/PD-L1 drugs currently on the US market. AstraZeneca is also developing its own immunotherapy for bladder cancer.

Opdivo, Keytruda and Tecentriq are classified as checkpoint inhibitors – drugs which block expression of certain tumor proteins, allowing the cancer cells to evade the immune system. By blocking these proteins, checkpoint inhibitors can work with the body’s immune cells to allow them to identify and destroy tumor cells.

Checkpoint inhibitors like the anti-PD1/PD-L1 drugs, represent an exciting area in oncology, with clinical trials showing promising results. Former President Jimmy Carter even attributes his cancer remission to his treatment with Keytruda after chemotherapy.



Tecentriq has been approved as a second-line therapy for patients with advanced or metastatic urothelial cancer. This type of bladder cancer accounts for 90 percent of all cases of the disease.

Tecentriq reduced tumor size in 14.8 percent of patients, in a Phase II clinical trial testing the drug’s efficacy. As the immunotherapy received an accelerated approval by the FDA, the agency will require Roche to perform further clinical trials to prove its effectiveness.

The drug also led to a 26 percent response rate in the 100 patients with increased PD-L1 expression in tumor-infiltrating immune cells, and generated a complete response in 12 patients. While the most common side effects included urinary tract infections, anemia and fatigue, three participants experienced server adverse drug reactions which proved fatal.

Roche is currently testing the drug to gauge its efficacy against other cancer types, including lung and breast cancer. Additional, FDA-approved indications would not only boost sales of Tecentriq, but would also make it a key competitor for Opdivo and Keytruda. Regardless of whether Tecentriq is granted additional approvals, all three immunotherapies are expected to reach blockbuster drug status by 2020.


Keywords: Immunotherapy, FDA, Bladder Cancer


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