Gedatolisib
An intravenous drug that blocks the whole PI3K/mTOR pathway, approved in July 2026 for hormone-positive breast cancer.
Celcuity's VIKTORIA-1 (with palbociclib and fulvestrant after CDK4/6 inhibitor progression in PIK3CA-wild-type HR+/HER2- breast cancer) supported FDA approval in July 2026, listed among that month's oncology approvals. Notable for activity in PIK3CA-wild-type disease.
1.Intravenous drug distributes to tumour
- Route
- IV infusion
- Schedule
- 180 mg weekly, 3 weeks on 1 week off, with palbociclib and fulvestrant
- Dose modifications
- Hold for grade 3 stomatitis or hyperglycaemia
- Monitoring
- Glucose, oral mucosa, blood counts
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: gedatolisib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- May 2025DesignationUS
Breakthrough Therapy designation, PIK3CA-wild-type HR+/HER2- breast cancer after CDK4/6 source
- Jul 2026ApprovalUS
HR+/HER2- advanced breast cancer after CDK4/6 inhibitor with palbociclib and fulvestrant (VIKTORIA-1) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2026 | HR+/HER2- advanced breast cancer after CDK4/6 inhibitor (July 2026) |
| Adverse event |
|---|
| Stomatitis |
| Neutropenia |
| Hyperglycaemia |
| Fatigue |
| Rash |
| Nausea |
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 B (physician-administered); commercial plans per formulary | 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:"Gedatolisib" OR ABSTRACT:"Gedatolisib" OR TITLE:"Revtorpyk" OR ABSTRACT:"Revtorpyk") 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 Gedatolisib, not a curated reading list.
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