Roche Withdraws Accelerated Approval for Tecentriq Cancer Treatment
August 27 2021 - 12:35PM
Dow Jones News
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Roche Holding AG said Friday that it has voluntarily withdrawn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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