The European Commission has approved Roche’s Tecentriq (atezolizumab) in combination with Abraxane (nab-paclitaxel) for certain adult patients with unresectable locally advanced or metastatic triple-negative breast cancer.
The approval of the combination marks the first cancer immunotherapy regimen to be available in Europe for triple-negative breast cancer, and will be available for patients whose tumours have PD-L1 expression of 1% or more and who have not received prior chemotherapy for metastatic disease.
The company also announced that its VENTANA PD-L1 (SP142) Assay is now CE marked and commercially available in the European Union as an aid for identifying patients with triple-negative breast cancer, who are eligible for treatment with the Tecentriq combination.
The approval of the monoclonal antibody was based on results from the Phase III IMpassion130 study, which found that the drug combo showed a statistically significant benefit in progression free survival, as well as significantly reducing the risk of disease worsening or death.
Sandra Horning, Roche’s chief medical officer, said that “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.”
She continued, “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.”
Breast cancer is the most common cancer among women, with more than two million diagnosed worldwide each year. Triple-negative breast cancer represents around 15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer.