By Ed Frankl

 

Roche Holding AG said Friday that it has voluntarily withdrawn the U.S. accelerated approval for Tecentriq to treat a type of metastatic breast cancer.

Tecentriq, used in combination with chemotherapy, is aimed to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer, or mTNBC, the Switzerland-based healthcare company said.

The decision was made in consultation with the U.S. Food and Drug Administration, based on the agency's assessment of the current mTNBC treatment landscape, and in accordance with the requirements of the accelerated approval program, Roche said.

It isn't related to changes in either the efficacy or safety associated with Tecentriq, Roche added.

The decision only impacts the mTNBC indication in the U.S. It doesn't affect other approved indications for Tecentriq in the U.S. or elsewhere, the company said.

Tecentriq was granted accelerated approval by the FDA for the mTNBC indication in March 2019.

Roche said it will work with the FDA over the coming weeks to complete the withdrawal process, and was notifying healthcare professionals in the U.S.

 

Write to Ed Frankl at edward.frankl@dowjones.com

 

(END) Dow Jones Newswires

August 27, 2021 12:22 ET (16:22 GMT)

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