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FDA Grants Accelerated Approval to Atezolizumab/Nab-Paclitaxel; Regular Approval Contingent on Confirmatory Trials

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Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) plus nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) for the treatment of adults with unresectable, locally advanced or metastatic, programmed cell death ligand 1 (PD-L1)-positive triple-negative breast cancer. PD-L1 status is determined by an FDA-approved test. 

Atezolizumab is a monoclonal antibody designed to bind with PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.

IMpassion130

This accelerated approval is based on data from the phase III IMpassion130 study and is contingent on the results of a confirmatory trial.

The IMpassion130 trial results demonstrated that atezolizumab plus nab-paclitaxel significantly reduced the risk of disease worsening or death by 40% compared with nab-paclitaxel alone (median progression-free survival = 7.4 vs. 4.8 months; hazard ratio = 0.60; 95% confidence interval = 0.48–0.77; P < .0001) in PD-L1–positive patients with unresectable locally advanced or metastatic triple-negative breast cancer who had not received prior chemotherapy for metastatic disease. Overall survival results were immature, with 43% of events in all randomly assigned patients (intent-to-treat), and further data will be shared with the FDA and presented at an upcoming medical meeting.

Safety in the atezolizumab plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual treatments, and no new safety signals were identified with the combination. The most common Grade 3 to 4 side effects (≥ 2 %) with atezolizuamb plus nab-paclitaxel and nab-paclitaxel alone, respectively, were neutropenia (8% vs 8%), decreased neutrophil count (5% vs 3%), peripheral neuropathy (6% vs 3%), fatigue (4% vs 3%), and anemia (3% vs 3%).

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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