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FDA approved Itovebi (Itovebi) for Endocrine-Resistant, PIK3CA-Mutated, HR-Positive, HER2-Negative, Locally Advanced or Metastatic Breast CancerFDA approved new breast cancer drug Itovebi for a specific type of advanced cancer

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Key Takeaway
Consider Itovebi with palbociclib and fulvestrant for PIK3CA-mutated, HR-positive, HER2-negative metastatic breast cancer after endocrine therapy recurrence.

The FDA has approved Itovebi, a kinase inhibitor, in combination with palbociclib and fulvestrant 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. This approval provides a new therapeutic option for a specific subset of breast cancer patients who have experienced recurrence after adjuvant endocrine therapy, addressing a clinical need in a population with limited alternatives. The indication requires detection of PIK3CA mutations using an FDA-approved test, emphasizing personalized medicine in oncology. Clinicians should note that Itovebi is administered orally once daily and is part of a combination regimen, with dosing adjustments based on renal function and adverse reactions. This approval is based on clinical studies referenced in the label, though specific trial outcomes are not detailed in the provided text.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Not reported in label.

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

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.

The U.S. Food and Drug Administration has approved a new medication called Itovebi for treating a specific type of advanced breast cancer. It's designed for adults with hormone receptor-positive, HER2-negative breast cancer that has spread or is locally advanced, and has a particular genetic change called PIK3CA mutation. This drug is taken by mouth once daily and is used in combination with two other cancer medications.

This approval is specifically for patients whose cancer has stopped responding to hormone therapy after previous treatment. Doctors will need to test for the PIK3CA genetic change before considering this treatment option. The FDA's decision means there's now another choice available for this group of patients who may have limited treatment alternatives.

It's important to understand that this approval doesn't mean Itovebi is right for everyone with breast cancer. The drug is specifically for a certain type of cancer with particular characteristics. Like all medications, Itovebi may have side effects, and doctors may need to adjust doses based on how patients respond.

If you or someone you know has breast cancer, the most important step is to talk with your healthcare team about all available options. They can help determine if this new treatment might be appropriate based on individual circumstances and test results.

What this means for you:
New FDA-approved breast cancer drug for specific patients with certain genetic changes.

Study Details

Study typeFda approval
PublishedOct 2024
View Original Abstract ↓
1 INDICATIONS AND USAGE 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 [see Clinical Studies (14.1) ] . ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant 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. ( 1 , 14.1 )
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