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The FDA has approved the PI3K inhibitor alpelisib (Piqray) for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

Single-agent pembrolizumab (Keytruda) did not meet a prespecified endpoint of superior overall survival compared with chemotherapy as a second- or third-line treatment for patients with metastatic triple-negative breast cancer, missing the primary endpoint of the phase III KEYNOTE-119 trial.