Inavolisib
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-INAVOLISIB |
|---|---|
| Type | Drug |
| Aliases | ItovebiІναволісіб |
| Status | pending_clinical_signoff |
| Diseases | DIS-BREAST |
| Sources | SRC-ESMO-BREAST-METASTATIC-2024 SRC-NCCN-BREAST-2025 |
Drug Facts
| Class | PI3K-alpha-selective inhibitor (mutant-selective; degrades mutant p110α) |
|---|---|
| Mechanism | Orally bioavailable PI3Kα inhibitor that selectively binds and promotes degradation of mutant p110α (PIK3CA-mut) over wild-type — improved tumor selectivity vs alpelisib. Combined with palbociclib + fulvestrant per INAVO120 in PIK3CA-mutated, HR+/HER2-, endocrine-resistant metastatic breast cancer. |
| Typical dosing | 9 mg PO once daily, with palbociclib 125 mg PO QD (3 weeks on / 1 week off) + fulvestrant 500 mg IM (standard schedule), until disease progression or unacceptable toxicity. |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-29 |
Notes
INAVO120 (NCT04191499): Phase III, PIK3CA-mut HR+/HER2- metastatic breast cancer with disease recurrence on/after adjuvant endocrine therapy. Inavolisib + palbociclib + fulvestrant vs placebo + palbociclib + fulvestrant. Median PFS 15.0 vs 7.3 mo (HR 0.43). FDA approval Oct 2024. Pre-treatment PIK3CA testing (tissue or ctDNA) required. Mutant-selective design rationale = lower hyperglycemia + rash burden than alpelisib while preserving efficacy. Trial-source SRC for INAVO120 not yet ingested into KB — FLAG for follow-up.
Used By
Regimens
REG-INAVOLISIB-PALBO-FULV-BREAST- Inavolisib + palbociclib + fulvestrant (HR+/HER2- PIK3CA-mutant 1L metastatic post-adjuva...