Roche has gained approval from the European Commission (EC) for Tecentriq (atezolizumab) with chemotherapy (Abraxane) to treat patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).
The treatment targets adults whose tumours have a PD-L1 expression of more than 1% and have not previously received chemotherapy for the disease.
Roche chief medical officer and global product development head Sandra Horning said: “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.”
EC granted the approval based on results obtained from the Phase III IMpassion130 study.
The progression-free survival (PFS) results indicated that Tecentriq plus nab-paclitaxel reduced the risk of progression by 38% when compared to nab-paclitaxel alone in people who tested positive for PD-L1 expression.
The combination of Tecentriq and nab-paclitaxel has shown a meaningful overall survival (OS) of seven months when compared to placebo and nab-paclitaxel for people with PD-L1-positive.
There are seven Phase III ongoing studies investigating the effect of Tecentriq in early and advanced stages of TNBC.
In March, the EC approved the use of Tecentriqin combination with Avastin (bevacizumab), paclitaxel and carboplatin as the first-line therapy for metastatic non-squamous non-small cell lung cancer (NSCLC).