Posted by Michael Wonder on 13 Nov 2018
FDA grants priority review to Roche’s Tecentriq in combination with Abraxane for the initial treatment of people with PD-L1-positive, metastatic triple-negative breast cancer
13 November 2018 - If approved, this Tecentriq (atezolizumab) combination would be the first cancer immunotherapy regimen for the treatment of PD-L1-positive, metastatic triple-negative breast cancer
Roche today announced the US FDA has accepted the company’s supplemental biologics license application and granted priority review for Tecentriq (atezolizumab) plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of unresectable locally advanced or metastatic triple-negative breast cancer in people whose disease expresses the PD-L1 protein, as determined by PD-L1 biomarker testing. The FDA is expected to make a decision on approval by 12 March 2019.
The application is based on data from the Phase III IMpassion130 study, which was presented at the European Society for Medical Oncology Congress and published in the New England Journal of Medicine in October 2018.
