Roche’s Tecentriq combo becomes first EU-approved immunotherapy for triple-negative breast cancer

pharmafile | August 30, 2019 | News story | Medical Communications, Sales and Marketing |  EMA, Europe, Roche, breast cancer, pharma, tecentriq 

Roche has announced the approval of Tecentriq (atezolizumab), in combination with Celgene’s chemotherapy drug Abraxane (nab paclitaxel), by the European Medicines Agency in the treatment of PD-L1-positive, unresectable locally advanced or metastatic triple-negative breast cancer, making it the first immunotherapy regimen available in the continent for this indication.  

The authorisation covers the combo’s use in patients who have not previously received chemotherapy for metastatic disease, and was supported by strong Phase 3 data evidencing an overall survival benefit of seven months compared to placebo plus Abraxane. Additionally, the combo was shown to reduce the risk of disease progression or death by 38% compared to the placebo combo.

Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development, commented on the decision: “For the past 30 years, we have been dedicated to transforming the lives of people with breast cancer. Now, we are pleased to build on this foundation with the news that the first immunotherapy treatment for triple-negative breast cancer is available to people in Europe with PD-L1-positive, metastatic triple-negative breast cancer. The European approval of this Tecentriq combination represents a significant step forward in the treatment of this aggressive breast cancer, where the unmet medical need is great.”

Matt Fellows