FDA approved Truqap (capivasertib) for HR+/HER2- Advanced Breast Cancer with PIK3CA/AKT1/PTEN AlterationsFDA approved new drug Truqap for certain advanced breast cancers.

Capivasertib is a kinase inhibitor. The exact mechanism in this indication is not fully described in the label.

Truqap, in combination with fulvestrant, is indicated for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

The recommended dosage is 400 mg orally twice daily (approximately 12 hours apart) with or without food, for 4 days followed by 3 days off. Continue until disease progression or unacceptable toxicity. Dose reductions for adverse reactions: first reduction to 320 mg twice daily for 4 days on/3 days off; second reduction to 200 mg twice daily for 4 days on/3 days off. For hyperglycemia, withhold or reduce dose based on fasting glucose levels. For diarrhea, withhold until recovery and consider dose reduction. Refer to fulvestrant prescribing information for its dosing. For premenopausal/perimenopausal women, administer an LHRH agonist; consider for men.

Trial data not available in label.

Warnings include hyperglycemia (monitor fasting glucose and HbA1C before and during treatment; manage with anti-diabetic medications and dose modifications) and diarrhea (manage with dose modifications). No contraindications listed in label.

Truqap provides a targeted therapy option for patients with HR+/HER2- advanced breast cancer harboring PIK3CA/AKT1/PTEN alterations after progression on endocrine therapy. It is used in combination with fulvestrant and requires genetic testing for patient selection.