Roche pulls accelerated approval for Tecentriq's US indication in PD-L1-positive, metastatic triple-negative breast cancer

Roche (ROG: SIX) has made the decision to voluntarily withdraw the US accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane; albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.

Roche made this decision following consultation with the US 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. This decision only impacts the mTNBC indication in the USA. It does not affect other approved indications for Tecentriq in the USA and outside the USA, including mTNBC. This is not related to any changes in either the efficacy or safety associated with Tecentriq, which generated revenues of around $1.7 billion for Roche in the first half of this year.

“TNBC remains the most challenging type of breast cancer to treat, which makes the decision to withdraw so difficult for us, as patients have had this medicine as an important option for more than two years,” said Dr Levi Garraway, Roche’s chief medical officer and Head of Global Product Development. “We appreciate the opportunity to have been able to help people with mTNBC in the US with Tecentriq through the accelerated approval process, which has brought many significant and novel therapies to patients. We remain dedicated to finding meaningful treatments for people living with this aggressive disease and will continue to study Tecentriq in mTNBC.”