Pivikto contains alpelisib, a targeted anticancer agent used in the treatment of specific types of advanced breast cancer. It is most effective in patients whose tumors have a PIK3CA gene mutation, which can drive cancer growth. Alpelisib is an oral medication and is often prescribed in combination with hormone therapy, particularly fulvestrant, for postmenopausal women and men with hormone receptor-positive, HER2-negative breast cancer.

Mechanism of Action

Alpelisib is a selective inhibitor of the phosphatidylinositol-3-kinase alpha (PI3Kα) isoform, which plays a key role in the PI3K/AKT signaling pathway. This pathway controls cell growth, metabolism, survival, and proliferation. In many cancers, especially breast cancers with PIK3CA mutations, this pathway becomes abnormally active, leading to uncontrolled cell growth. By blocking PI3Kα, alpelisib helps slow down or stop cancer cell progression, particularly in tumors that are driven by these genetic changes.

Uses

Pivikto is used in combination with fulvestrant for the treatment of:

• Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer

• Specifically in adults whose disease has progressed on or after endocrine therapy

• Only in patients with confirmed PIK3CA mutation, which is determined by an FDA-approved test

  Adverse Effects

  Common side effects

  • High blood sugar levels or hyperglycemia

  • Diarrhea

  • Nausea

  • Decreased appetite

  • Fatigue

  • Skin rash

  • Weight loss