Roche Joins AstraZeneca in Ditching US Bladder Cancer Indication for Immunotherapies

By John Miller

March 09, 2021

ZURICH (Reuters) - Roche on Monday joined AstraZeneca in withdrawing cancer immunotherapies from U.S. use for bladder cancer that has already been treated with platinum-based chemotherapy, after follow-up studies failed to meet goals.

Basel-based Roche said in a statement it was withdrawing the U.S. indication for Tecentriq, with some $3 billion in 2020 sales, in prior-platinum treated metastatic urothelial carcinoma.

In February, AstraZeneca announced a similar move for its $2 billion-per-year drug Imfinzi.

Both Tecentriq and Imfinzi aim to take the brakes off the immune system by binding with a protein called PD-L1, or programmed death-ligand 1, expressed on tumor cells and which is seen in helping prevent the immune system from recognising it as cancer.

After so-called accelerated U.S. Food and Drug Administration (FDA) approval for bladder cancer, however, the drugs failed to deliver positive follow-up data required by regulators, prompting discussions that led to the medicines being dropped in this indication.

Other treatment areas for Tecentriq and Imfinzi are not impacted by the companies' separate moves.

"This decision was made in consultation with the U.S. Food and Drug Administration as part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals," Roche said.

Tecentriq initially won accelerated FDA approval in 2016 for people previously treated for the most common form of bladder cancer, but was required to gather follow-up data in order to win regular approval.

Doubts emerged quickly, however, as Roche said in 2017 Tecentriq failed to show a survival benefit in second-line bladder cancer, raising questions over whether the FDA should reverse the accelerated approval.

Tecentriq's other approved indications include non-small cell lung cancer, small cell lung cancer, certain types of bladder cancer, a kind of triple negative breast cancer and for liver cancer.

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