This brand name is authorized in United States. It is also authorized in Austria, Estonia, France, Italy, Lithuania, Romania.
The drug ITOVEBI contains one active pharmaceutical ingredient (API):
1
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UNII
L4C1UY2NYH - INAVOLISIB
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Inavolisib is an inhibitor of the phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) catalytic subunit alpha isoform protein (p110α; encoded by the PIK3CA gene). In addition, inavolisib promotes the degradation of mutated p110α (mutant degrader). The PI3K signalling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations. With its dual mechanism of action, inavolisib inhibits the activity of downstream PI3K pathway targets, including AKT, resulting in reduced cellular proliferation and induction of apoptosis in PIK3CA-mutated breast cancer cell lines. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ITOVEBI Tablet | MPI, US: SPL/PLR | FDA, National Drug Code (US) | |
| ITOVEBI Film-coated tablet | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L01EM06 | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EM Phosphatidylinositol-3-kinase (Pi3K) inhibitors | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| EE | Ravimiamet | 3133471, 3133482 |
| FR | Base de données publique des médicaments | 61001565, 68964635 |
| IT | Agenzia del Farmaco | 052380019, 052380021 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1104264, 1104265 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W71306001, W71307001 |
| US | FDA, National Drug Code | 50242-079, 50242-084 |
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