Itovebi, inavolisib
Named-patient access overview. Itovebi is coordinated by Reserve Meds for international patients via physician-led cross-border sourcing.
About Itovebi
Itovebi (inavolisib) is manufactured by Genentech, a member of the Roche Group, and was approved by the US FDA in 2024 for use in combination with palbociclib and fulvestrant in adults with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer whose disease has recurred on or after adjuvant endocrine therapy. It is an oral, selective PI3K-alpha inhibitor with degrader activity on the mutant p110-alpha subunit, which is the mechanism studied in the INAVO120 Phase 3 trial supporting the indication.
A PIK3CA mutation must be confirmed by an FDA-approved test on tumor tissue or plasma before treatment, and Itovebi is taken by mouth once daily as part of the triplet regimen set out in the prescribing information, with monitoring for hyperglycemia, stomatitis, diarrhea, and rash. For international patients, Itovebi may be coordinated through Named Patient Program or personal-import pathways with the destination country's regulator and the patient's treating oncologist handling the documentation.
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How Reserve Meds coordinates Itovebi
- Patient or treating physician submits a named-patient request.
- Clinical team verifies appropriateness of Itovebi for the patient and destination country.
- Treating physician issues prescription and clinical justification.
- Country-specific NPP / personal-import documentation is prepared.
- Itovebi is sourced from a DSCSA-compliant US specialty wholesaler with full serial traceability.
- Shipment is coordinated to the patient's physician or hospital pharmacy (cold-chain where required).
Access by country
Reserve Meds publishes a detailed country deep-dive for Itovebi in every market we coordinate. Each page below covers the destination-country regulatory pathway (named-patient framework), real costs in local currency and USD, indicative timelines, physician-credential requirements, and cold-chain handling for the route into that country. Tap any country to read the full deep-dive.
Start a request for Itovebi
Submit a 60-second intake. Our clinical team will reach out as our first cohort opens with case-specific feasibility, timeline, and a formal quote.