Inavolisib
Inavolisib is a PI3K drug that also destroys the mutant protein, approved in 2024 with palbociclib and fulvestrant for PIK3CA-mutant breast cancer.
INAVO120: PFS 15.0 vs 7.3 months in endocrine-resistant PIK3CA-mutant HR+/HER2- breast cancer; OS benefit reported 2025. Roche/Genentech.
1.Inavolisib binds mutant and wild-type PI3Kα
- Route
- Oral
- Schedule
- 9 mg once daily with palbociclib and fulvestrant
- Dose modifications
- Reduce to 6 then 3 mg for hyperglycaemia, stomatitis, diarrhoea
- Monitoring
- Fasting glucose weekly for 4 weeks then every 4 weeks; HbA1c; oral care
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). FDA-approved October 2024.
- Commercial insurance
- covered with prior authorisation
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. PIK3CA mutation and endocrine-resistant disease per the label.
- Assistance programmes
- Genentech Access Solutions
- Genentech Patient Foundation — Free medicine for eligible patients regardless of insurance type.
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
- Notes
- Recently licensed; a NICE appraisal is scheduled or in progress. Interim access may be possible via the CDF interim funding route once NICE issues positive draft guidance.
Sources: NICE search: inavolisib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 10 Oct 2024ApprovalUS
PIK3CA-mutant HR+/HER2- endocrine-resistant advanced breast cancer with palbociclib and fulvestrant (INAVO120) source
- Jun 2025Label changeUS
OS benefit added to label source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2024 | PIK3CA-mutant HR+/HER2- advanced breast cancer with palbociclib and fulvestrant |
| Adverse event |
|---|
| Neutropenia |
| Hyperglycaemia |
| Stomatitis |
| Diarrhoea |
| Rash |
| Fatigue |
INAVO120 triplet: most common grade 3-4 (from palbociclib). Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | genentech-access.com |
| United Kingdom | NICE: appraisal for PIK3CA-mutant HR+ breast cancer (2025-26) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Inavolisib" OR ABSTRACT:"Inavolisib" OR TITLE:"Itovebi" OR ABSTRACT:"Itovebi") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Inavolisib, not a curated reading list.