The US FDA have granted accelerated approval for Roche’s Tecentriq® (atezolizumab) in combination with Abraxane® for individuals with PD-L1-positive, metastatic triple-negative breast cancer.
This indication is approved under accelerated approval based on progression-free survival (PFS) and PD-L1 will be determined in patients by an FDA-approved test.
“The FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic triple-negative breast cancer, a disease with high unmet medical need,” commented Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development.
“This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease,” Horning added.
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The accelerated approval is based on data from the Phase III IMpassion130 study, which demonstrated that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 40% compared with nab-paclitaxel alone in PD-L1-positive patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease.
Overall survival (OS) results were immature with 43% of events in all randomized patients (intent-to-treat), and further data will be shared with the FDA and presented at an upcoming medical meeting. Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines and no new safety signals were identified with the combination.