The FDA granted priority review to a supplemental biologics license application that seeks approval of atezolizumab in combination with nab-paclitaxel for first-line treatment of unresectable locally advanced or metastatic PD-L1-positive, triple-negative breast cancer.
The FDA based the designation on results from the randomized phase 3 IMpassion130 study, which included 902 patients with previously untreated metastatic triple-negative disease.
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