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FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer.
Narayan P, Prowell TM, Gao JJ, Fernandes LL, Li E, Jiang X, Qiu J, Fan J, Song P, Yu J, Zhang X, King-Kallimanis BL, Chen W, Ricks TK, Gong Y, Wang X, Windsor K, Rhieu SY, Geiser G, Banerjee A, Chen X, Reyes Turcu F, Chatterjee DK, Pathak A, Seidman J, Ghosh S, Philip R, Goldberg KB, Kluetz PG, Tang S, Amiri-Kordestani L, Theoret MR, Pazdur R, Beaver JA. Narayan P, et al. Among authors: rhieu sy. Clin Cancer Res. 2021 Apr 1;27(7):1842-1849. doi: 10.1158/1078-0432.CCR-20-3652. Epub 2020 Nov 9. Clin Cancer Res. 2021. PMID: 33168657 Free PMC article. Clinical Trial.