Article
FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer.
Clinical cancer research : an official journal of the American Association for Cancer Research - 1 Apr 2021
Narayan Preeti, Prowell Tatiana M, Gao Jennifer J, Fernandes Laura L, Li Emily, Jiang Xiling, Qiu Junshan, Fan Jianghong, Song Pengfei, Yu Jingyu, Zhang Xinyuan, King-Kallimanis Bellinda L, Chen Wei, Ricks Tiffany K, Gong Yutao, Wang Xing, Windsor Katherine, Rhieu Steve Y, Geiser Gerlie, Banerjee Anamitro, Chen Xiaohong, Reyes Turcu Francisca, Chatterjee Deb K, Pathak Anand, Seidman Jeffrey, Ghosh Soma, Philip Reena, Goldberg Kirsten B, Kluetz Paul G, Tang Shenghui, Amiri-Kordestani Laleh, Theoret Marc R, Pazdur Richard, Beaver Julia A
Abstract excerpt
On May 24, 2019, the FDA granted regular approval to alpelisib in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, HER2-negative, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Approval...
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