FDA approved Ibrance (palbociclib) for PIK3CA-Mutated Breast CancerFDA approved Ibrance combination for certain advanced breast cancer patients.

Palbociclib is a kinase inhibitor that inhibits cyclin-dependent kinases 4 and 6 (CDK4 and CDK6). These kinases are involved in the regulation of cell cycle progression. In combination with inavolisib and fulvestrant, it targets the PI3K/AKT/mTOR pathway and estrogen receptor signaling.

Ibrance is indicated in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

The recommended dose of Ibrance is 125 mg taken orally once daily for 21 consecutive days followed by 7 days off treatment (28-day cycle). It can be taken with or without food. Tablets should be swallowed whole and not chewed, crushed, or split. If a dose is missed or vomited, the next dose should be taken at the usual time. Dose reductions for adverse reactions are recommended: first reduction to 100 mg/day, second reduction to 75 mg/day; discontinue if further reduction is needed. For hematologic toxicities, dose modifications are based on CTCAE grade. For non-hematologic toxicities, withhold for Grade ≥3 until resolution. Pre/perimenopausal women should also receive an LHRH agonist. For men, consider LHRH agonist therapy.

Trial data not available in label.

Not reported in label.

Ibrance in combination with inavolisib and fulvestrant is indicated for patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced or metastatic breast cancer who have recurred on or after adjuvant endocrine therapy. It is a targeted therapy option for this molecularly defined population.