Roche has decided to voluntarily withdraw the US accelerated approval for Tecentriq (atezolizumab) in combination with Abraxane (nab-paclitaxel) to treat patients with PD-L1-positive metastatic triple-negative breast cancer (mTNBC).
Tecentriq is a monoclonal antibody that can bind with Programmed Death Ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors.
The company stated that Tecentriq, either alone or in combination with targeted therapies and/or chemotherapies, is approved in the US, EU as well as in other countries worldwide for various forms of non-small cell and small cell lung cancer.
It is also approved for certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.
Roche said that the decision does not affect Tecentriq’s other indications in the US and abroad, including for mTNBC.
In March 2019, Tecentriq first secured an accelerated FDA approval for the mTNBC indication depending on the results from the Phase III IMpassion130 study.
Roche chief medical officer and Global Product Development head Levi Garraway said: “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.
“We remain dedicated to finding meaningful treatments for people living with this aggressive disease and will continue to study Tecentriq in mTNBC.”
The company will work with the US FDA to complete the withdrawal process over the coming weeks.