What is the name of the drug and what does it do?
Itovebi (pronounced eye-TOH-veh-bee), generic name inavolisib, is a prescription medication used in combination with two other drugs, palbociclib and fulvestrant, to treat adults with certain types of advanced or metastatic breast cancer. This treatment is specifically for hormone receptor-positive, HER2-negative breast cancer that has a PIK3CA mutation and has become resistant to endocrine therapy.
How does it work?
Itovebi is a kinase inhibitor that targets a specific mutation in the PIK3CA gene. This gene mutation often leads to cancer cell growth and survival. By blocking the activity of this gene, Itovebi helps slow the progression of the cancer and may shrink tumors when used with other treatments like palbociclib and fulvestrant.
What did the research discover?
In a clinical trial with 324 patients, Itovebi showed significant benefits in slowing the progression of advanced breast cancer. Patients treated with Itovebi, palbociclib, and fulvestrant had a median progression-free survival of 15 months, compared to 7.3 months for those who received a placebo with the same combination. Additionally, 58% of patients taking Itovebi experienced tumor shrinkage, compared to 25% of patients in the placebo group.
What are some of the side effects?
The most common side effects of Itovebi include:
- Increased blood sugar levels (hyperglycemia)
- Mouth sores (stomatitis)
- Diarrhea
- Nausea
- Fatigue
- Decreased appetite
- Skin rash
- Headache
More serious side effects may include severe diarrhea, dehydration, and high blood sugar levels that require medical attention. Patients are advised to monitor their symptoms closely and report any concerning changes to their doctor immediately.
What are the dosage recommendations and how is it prescribed?
Itovebi is taken as an oral tablet, once daily, at the same time each day, with or without food. The recommended dose is 9 mg per day, but adjustments may be needed based on side effects. Itovebi is always prescribed alongside palbociclib and fulvestrant, which have their own specific dosing schedules.
Patients should swallow the tablet whole and avoid chewing or crushing it. If a dose is missed, it can be taken within nine hours of the usual time; otherwise, the missed dose should be skipped.
Source:
U.S. Food and Drug Administration. Full prescribing information: [Label for NDA 219249]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219249s001lbl.pdf. Accessed 2024 Nov 21.
