Tecentriq’s Indication for Previously Treated Metastatic Bladder Cancer Pulled by FDA, Manufacturer


If patients were receiving Tecentriq for prior platinum-based treated metastatic urothelial carcinoma, they should discuss next best steps with their health care providers.

Tecentriq’s indication for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or after platinum-based chemotherapy has been pulled by the Food and Drug Administration (FDA) and the drug’s manufacturer, Roche.

If patients were receiving Tecentriq for this indication, they should discuss next best steps with their health care providers, according to a news release from the manufacturer.

The FDA originally granted Tecentriq an accelerated approval for this indication in 2016 based on data from the IMvigor210 study, which demonstrated that treatment with the PD-L1 inhibitor was associated with promising overall response rates in patients.

Roche consulted with the FDA on the decision, as part of an evaluation of drugs that were granted accelerated approvals that have not yet met the main goal needed to gain a regular approval.

Drugs are granted a conditional accelerated approval if the agency deems it fulfills an unmet medical need for a serious condition. However, the manufacturer has to complete further study to confirm the drug warrants a regular approval.

For Tecentriq to stay approved for this indication, it had to meet certain overall survival endpoints in a certain patient population. Updated findings from the IMvigor211 trial showed that it did not meet that endpoint. As a result, the agency designated a different study — the IMvigor130 trial — to see if the drug could meet its primary endpoint.

Although the trial is ongoing, Roche voluntarily pulled this indication as the treatment landscape in this patient population has recently evolved with the emergence of new treatment options.

While this indication for Tecentriq was pulled, it does not affect the drug’s approval status for other cancer types.

“The Accelerated Approval Program allows people with difficult-to-treat cancers to receive certain new therapies earlier,” said Roche’s Chief Medical Officer and Head of Global Product Development Dr. Levi Garraway in the release. “While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients.”

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