Novartis Announces FDA Approval of Expanded Indication for PI3Kα Inhibitor Alpelisib in HR+/HER2-, PIK3CA-Mutated Advanced Breast Cancer
Novartis
Drug Development and Manufacturing
Recently, the FDA approved Novartis' PI3Kα inhibitor alpelisib for expanded indications, including premenopausal and perimenopausal women in the treatment of breast cancer. The indication is now revised to: in combination with fulvestrant for the treatment of postmenopausal adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated advanced or metastatic breast cancer as detected by an FDA-approved test.
In May 2019, Alpelisib was approved by the FDA for marketing. The indication is: in combination with fulvestrant for the treatment of postmenopausal women and men with HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer detected by the FDA, becoming the first treatment targeting PIK3CA mutations in HR+/HER2- advanced breast cancer.
PIK3CA is the most common mutated gene in HR+/HER2- breast cancer. Approximately 40% of patients with HR+/HER2- breast cancer carry this mutation. PIK3CA mutations are associated with tumor growth, resistance to endocrine therapy, and poor overall prognosis.
In December 2023, Roche's PI3Kα inhibitor inavolisib, used in combination with palbociclib and fulvestrant for the first-line treatment of patients with PIK3CA-mutated, HR-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer, met the primary endpoint of progression-free survival (PFS) in the Phase III INAVO120 study.
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