Prescription medicine
Inavolisib Brand names: Itovebi
Inavolisib (Itovebi) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the inavolisib FDA label on DailyMed (effective April 21, 2026, Genentech, Inc.); the NDA 219249 record on Drugs@FDA; every inavolisib label on DailyMed.
Highlights of the record
FDA label of April 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageITOVEBI, 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) ].
Forms and strengths
- 3 mg
- 9 mg
Film-coated tablet.
On the market
- Earliest approval on file
- October 10, 2024 Itovebi, Genentech Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 14, 2038 Itovebi tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 527 through July 30, 2026
What is inavolisib used for?
From the label: indications and usageITOVEBI, 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) ]. […]
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Itovebi), Genentech, Inc., effective April 21, 2026 (SPL set 5de59f5b-e5db-410f-b692-658686ef4107), via openFDA; the full label on DailyMed
Is there a generic for inavolisib (Itovebi)?
No generic inavolisib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Itovebi tablets: the compound patent runs to April 26, 2038, and the last listed entry to June 14, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the inavolisib label say about other medicines?
The inavolisib label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fulvestrant | warnings and precautions | Advise patients of potential risk to a fetus and to use effective non-hormonal contraception. ( 5.4 , 8.1 , 8.3 ) Refer to the Full Prescribing Information of palbociclib and fulvestrant for pregnancy and contraception information. |
| Loperamide | warnings and precautions | Advise patients to start anti-diarrheal treatment, increase oral fluids, and notify their healthcare provider if severe diarrhea occurs. |
| Palbociclib | warnings and precautions | Advise patients of potential risk to a fetus and to use effective non-hormonal contraception. ( 5.4 , 8.1 , 8.3 ) Refer to the Full Prescribing Information of palbociclib and fulvestrant for pregnancy and contraception information. |
Source: FDA drug label (Itovebi), Genentech, Inc., effective April 21, 2026 (SPL set 5de59f5b-e5db-410f-b692-658686ef4107), via openFDA; the full label on DailyMed
What do FAERS reports show for inavolisib?
The FDA Adverse Event Reporting System holds 527 reports that list inavolisib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 25 are coded as a death and 177 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Inavolisib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other