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FDA Grants Accelerated Approval to Atezolizumab/ Nab-paclitaxel in Triple-Negative Breast Cancer


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ON MARCH 8, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) for the treatment of adults with unresectable, locally advanced or metastatic, PD-L1–positive triple-negative breast cancer. PD-L1 status is determined by an FDA-approved test. This accelerated approval is based on data from the phase III IMpassion130 study and is contingent on the results of a confirmatory trial.

Atezolizumab is a monoclonal antibody that binds with PD-L1 expressed on tumor cells and immune cells, blocking interactions with PD-1 and B7.1 receptors.


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