Approved for the treatment of postmenopausal patients with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer that has been detected by an FDA-approved test and progressed during or after an endocrine-based therapy regimen, in combination with fulvestrant.
Alpelisib is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer.
It is for ER positive breast cancers that have PI3K mutations, and that is about 40% of ER positive breast cancers.
The therascreen PIK3CA RGQ PCR Kit, a companion diagnostic test for the detection of PIK3CA mutation via a tissue and/or liquid biopsy is required.
It is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer.
SOLAR-1 clinical trial of 572 postmenopausal women and men with HR-positive, HER2-negative, advanced or metastatic breast cancer that had progressed during or after therapy with aromatase inhibitor: adding alpelisib to fulvestrant therapy significantly prolonged progression-free survival in patients with the PIK3CA mutation.
Side effects: high blood sugar levels, increase in creatinine, diarrhea, rash, decrease in lymphocyte count in the blood, elevated liver enzymes, nausea, fatigue, low red blood cell count, increase in lipase, decreased appetite, stomatitis, vomiting, weight loss, low calcium levels, aPTT, and hair loss.
Hyperglycemia seen in almost 64% of patients, rash is common at greater than 50% of patients, as is diarrhea at 58%.