medwireNews: The EMA has adopted a positive opinion for the use of alpelisib alongside fulvestrant in patients with locally advanced and metastatic breast cancer with an activating PIK3CA mutation.
The PI3Kα inhibitor is indicated for postmenopausal women and men with PIK3CA-mutated, hormone receptor-positive, HER2-negative disease who have progressed after endocrine monotherapy.
The decision is based on results from the SOLAR-1 trial demonstrating a significant improvement in progression-free survival with use of alpelisib plus fulvestrant versus placebo plus fulvestrant.
The most common adverse events associated with alpelisib use include elevated levels of glucose, creatinine, and liver enzymes, gastrointestinal symptoms, anemia, and prolongation of activated partial thromboplastin time.
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