Roche has withdrawn its blockbuster cancer immunotherapy Tecentriq (atezolizumab) as a treatment for women with a form of triple-negative breast cancer (TNBC).

The FDA granted Tecentriq accelerated approval in March 2019 in combination with chemotherapy for treating adults with unresectable locally advanced or metastatic TNBC whose tumors express the biomarker PD-L1. The immunotherapy was the first to be approved for this indication.

But a required confirmatory trial failed to show the drug improved progression-free survival in TNBC patients, though an FDA advisory committee voted in late April to recommend that the drug’s accelerated approval be maintained for the time being.

Based on follow-up talks with the agency, Roche has now decided to withdraw the drug’s indication, but says it will continue to evaluate Tecentriq as a treatment for TNBC.