Itovebi FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 11, 2024.

FDA Approved: Yes (First approved October 10, 2024)
Brand name: Itovebi
Generic name: inavolisib
Dosage form: Tablets
Company: Genentech, Inc.
Treatment for: Breast Cancer

Itovebi (inavolisib) is a phosphatidylinositol 3-kinase (PI3K) alpha inhibitor used for the combination treatment of PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.

Itovebi is 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.
Hormone receptor (HR)-positive breast cancer is the most common type of all breast cancers, accounting for approximately 70% of all cases. It is characterized by tumor cells that have receptors that attach to the hormones estrogen and/or progesterone, which can contribute to tumor growth.
The PI3K signalling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations. Mutations in the PIK3CA gene may cause the PI3K enzyme to become overactive, which may cause cancer cells to grow. Inavolisib works by inhibiting PIK3CA.
FDA approval of Itovebi was based on the results of the Phase III INAVO120 study, which showed the Itovebi (inavolisib)-combination regimen reduced the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone (15.0 months vs. 7.3 months) in the first-line setting, demonstrating a statistically significant and clinically meaningful benefit.
Itovebi tablets are administered orally, once daily, with or without food.
Warnings and precautions associated with Itovebi include hyperglycemia, severe stomatitis, diarrhea, and embryo-fetal toxicity.
Common adverse reactions include stomatitis, diarrhea, fatigue, nausea, rash, decreased appetite, COVID-19 infection, and headache.
Common laboratory abnormalities include decreased neutrophils, decreased hemoglobin, increased fasting glucose, decreased platelets, decreased lymphocytes, decreased calcium, decreased potassium, increased creatinine, increased ALT, decreased sodium, and decreased magnesium.

Development timeline for Itovebi

Date	Article
Oct 10, 2024	Approval FDA Approves Itovebi (inavolisib) for the Combination Treatment of Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
May 29, 2024	FDA Grants Priority Review to Roche’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation
May 28, 2024	FDA Grants Priority Review to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
May 20, 2024	FDA Grants Breakthrough Therapy Designation to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
Dec 8, 2023	Genentech’s Inavolisib Combination Reduces the Risk of Disease Progression by 57% in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
Dec 4, 2023	Genentech Announces Positive Phase III Results for Inavolisib Combination in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
Dec 4, 2023	Genentech Announces Positive Phase III Results for Inavolisib Combination in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

Further information

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