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Roche withdraws US approval for Tecentriq in mTNBC

Roche has voluntarily withdrawn its US accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumours express PD-L1.

Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.

Tecentriq was granted accelerated approval by the US Food and Drug Administration (FDA) for the mTNBC indication in March 2019 based on the progression-free survival (PFS) results of the Phase III IMpassion130 study. Continued approval was contingent upon the results of IMpassion131, which did not meet its primary endpoint of PFS.

Roche has been working with the FDA on a possible alternative post-marketing requirement (PMR) for Tecentriq in this indication but has said due to “recent changes in the treatment landscape” the FDA no longer considers it appropriate to maintain the accelerated approval.

“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 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,” he added.