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FDA Medication Tracker

← All approvals · Cancer · 2024

Itovebi (inavolisib)

The FDA approved Itovebi (inavolisib) on October 10, 2024 to treat locally advanced or metastatic breast cancer.
Brand name
Itovebi
Generic name
inavolisib
FDA approval date
October 10, 2024
Approved use (FDA wording)
To treat locally advanced or metastatic breast cancer
Company
Genentech Inc.
Application
NDA219249
Dosage form / route
TABLET · ORAL
Drug class (EPC)
Kinase Inhibitor [EPC]
Boxed warning on label
Not listed
Category on this site
Cancer

Indications and usage, from the FDA label

ITOVEBI, 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) ] . ITOVEBI is a kinase inhibitor 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 b…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.