FDA Approves Itovebi (Itovebi) for Endocrine-Resistant, PIK3CA-Mutated, HR-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Not reported in label.

Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. Patient selection is based on the presence of one or more PIK3CA mutations in plasma specimens.

The recommended dosage of Itovebi is 9 mg taken orally once daily, with or without food, until disease progression or unacceptable toxicity. It is administered in combination with palbociclib (125 mg orally once daily for 21 days followed by 7 days off) and fulvestrant. For premenopausal and perimenopausal women, administer a luteinizing hormone-releasing hormone (LHRH) agonist in accordance with local clinical practice; for men, consider an LHRH agonist. Before initiating, evaluate fasting plasma glucose (FPG)/blood glucose (FBG) and hemoglobin A1C (HbA1C) and optimize blood glucose. Dosage modifications include reductions to 6 mg or 3 mg daily for adverse reactions, with permanent discontinuation if unable to tolerate the second reduction. Reduce the starting dose in patients with moderate renal impairment. If a dose is missed, take within 9 hours; after more than 9 hours, skip and resume next scheduled dose. If vomiting occurs, do not take an additional dose that day.

Trial data not available in label.

Not reported in label.

Itovebi is used in combination with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer after recurrence post-adjuvant endocrine therapy.