The U.S. Food and Drug Administration (FDA) granted accelerated approval to Roche’s Genentech for Tecentriq (atezolizumab) plus chemotherapy, Abraxane, to treat unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in patients whose tumors expressed PD-L1.
The drug was granted accelerated approval based on progression-free survival (PFS). Under this approval process, confirmatory clinical trials have to be continued, or the approval can be canceled. The FDA’s Accelerated Approval Program focuses on conditional approval for drugs that fill an unmet medical need for a serious or life-threatening illness.
The accelerated approval was built on data from the Phase III IMpassion130 trial, showing that Tecentriq plus nab-paclitaxel significantly cut the risk of PFS by 40 percent compared with nab-paclitaxel alone in PD-L1-positive patients with TNBC who hadn’t received previous chemotherapy. Genentech indicates that overall survival (OS) data were “immature,” and more data would be provided to the FDA and presented at an upcoming medical meeting.
Tecentriq is a monoclonal antibody that binds with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells. It blocks interactions with both PD-1 and B7.1 receptors. When it inhibits PD-L1, it allowed the activation of T-cells, allowing these immune cells free rein to attack the cancer.