Inavolisib FDA Approval Status

Last updated by Judith Stewart, BPharm on Aug 26, 2024.

FDA Approved: No
Generic name: inavolisib
Company: Genentech, Inc.
Treatment for: Breast Cancer

Inavolisib is a phosphatidylinositol 3-kinase (PI3K) alpha inhibitor in development for the combination treatment of PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer.

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 tumour 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.
Inavolisib is currently being investigated in three company-sponsored Phase 3 clinical studies (INAVO120, INAVO121, INAVO122) in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations.
The U.S. Food and Drug Administration has granted Priority Review to inavolisib in combination with palbociclib (Ibrance) and fulvestrant in adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
The Priority Review is based on the positive Phase III INAVO120 results, which showed the inavolisib-based regimen more than doubled progression-free survival, reducing the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone.
Based on the Priority Review designation, the FDA has set a Prescription Drug User Fee Act date of 27 November, 2024.

Development timeline for inavolisib

Date	Article
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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