NDAORALTABLETPriority Review
Approved
Oct 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
15
Data completeness
6/8 — Strong
Priority Review
ITOVEBI (inavolisib) by Roche is phosphoinositide 3-kinase alpha inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2024.
Drug data last refreshed 5h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ITOVEBI (inavolisib) is an oral phosphoinositide 3-kinase alpha (PI3K-α) inhibitor approved by the FDA on October 10, 2024. It is a small-molecule kinase inhibitor designed to treat cancers driven by PI3K-α pathway dysregulation. The drug represents Roche's entry into a competitive kinase inhibitor space with a novel mechanism targeting a specific kinase mutation.
Growth12.0 years to LOE
As a newly approved (October 2024) growth-stage product from Roche, ITOVEBI will require significant commercial investment in field sales, payer management, and patient education to establish market penetration against entrenched competitors.
Mechanism of Action
Phosphoinositide 3-Kinase alpha Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (15)
A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.
Started Jun 2026
160 enrolled
Breast Cancer
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
Started Apr 2026
80 enrolled
Breast Cancer
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Started Mar 2026
100 enrolled
Metastatic Castration-Resistant Prostate Cancer
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
Started Feb 2026
80 enrolled
Breast Cancer
A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer
Started Feb 2026
0Colorectal Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.