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All Oncology News

The FDA approved a supplemental new drug application to update the label for gilteritinib to include final analysis data from the phase III ADMIRAL trial, which demonstrated an improvement in overall survival with the FLT3 inhibitor compared with salvage chemotherapy in adult patients with relapsed/refractory FLT3-mutant acute myeloid leukemia.

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.