What kind of medicine is Apelix and what are its indications?

Alpelisib (Alpelisib) is a PI3K inhibitor indicated for use in combination with fulvestrant for the treatment of hormone receptor-positive, human epidermal growth factor receptor type 2 (HER2)-negative, advanced or metastatic breast cancer in postmenopausal women and men during or after endocrine-based therapy with an FDA-approved diagnostic test such as therascreen PIK3CA RGQ PCR kit) detects tumors containing mutations in the catalytic phosphatidylinositol-3-kinase subunit alpha (PIK3CA).

Apelixis is a targeted therapy called a PI3K inhibitor that blocks the PI3K pathway. The PI3K pathway helps all cells, including healthy cells and cancer cells, get the energy they need. When this pathway is overactivated by mutations in the PIK3CA gene, it allows cancer cells to survive and grow. PI3K inhibitors block this pathway with the goal of killing cancer cells. Different mutations in the PIK3CA gene produce different forms of the PI3 protein, which researchers call isoforms. There are several isoforms of PI3; one of them is the alpha isoform. Apelvis specifically targets the alpha subtype.

Apelix is only effective against breast cancer with PIK3CA mutations. Before patients take the drug, their cancer must be tested to make sure the mutation is present. Advanced breast cancer is cancer that has come back or spread to the chest wall below the breast. Metastatic breast cancer is advanced cancer that has spread to parts of the body other than the breast, such as the bones or liver. Clinical guidelines generally recommend that postmenopausal women and men with hormone receptor-positive, HER-2-negative, PIK3CA-mutated advanced or metastatic breast cancer receive endocrine therapy (such as an aromatase inhibitor with or without a cyclin-dependent kinase [CDK] 4/6 inhibitor) in combination with apelvis and fulvestrant.