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An intravenous drug that blocks the whole PI3K/mTOR pathway, approved in July 2026 for hormone-positive breast cancer.
Gedatolisib is an intravenous pan-class I PI3K and mTORC1/2 inhibitor, given at 180 mg weekly for 3 weeks of every 4 alongside palbociclib and fulvestrant, so it shuts down the whole PI3K/AKT/mTOR axis rather than one isoform. Celcuity's VIKTORIA-1 trial tested it after progression on a CDK4/6 inhibitor in PIK3CA-wild-type HR-positive, HER2-negative advanced breast cancer and supported FDA approval in July 2026, listed among that month's oncology approvals. Its notable feature is activity in PIK3CA-wild-type disease, a group without a targeted PI3K-pathway option until now. Stomatitis, neutropenia, hyperglycaemia and rash are the main adverse events. Results in the PIK3CA-mutant cohort, and whether weekly infusions are acceptable against oral alternatives, are open. For a newcomer: a pathway-wide PI3K/mTOR blocker for hormone-driven breast cancer after CDK4/6 therapy stops working.
Pan-class I PI3K and mTORC1/2 inhibitor, intravenous weekly. Connects to PIK3CA / PI3K-alpha and AKT.
1.Intravenous drug distributes to tumour
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Sources: NICE search: gedatolisib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Breakthrough Therapy designation, PIK3CA-wild-type HR+/HER2- breast cancer after CDK4/6 source
HR+/HER2- advanced breast cancer after CDK4/6 inhibitor with palbociclib and fulvestrant (VIKTORIA-1) source
| 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.
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Query 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.
Shares AKT, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, PIK3CA / PI3K-alpha.
Shares AKT, PIK3CA / PI3K-alpha, PI3K / AKT / mTOR, HR-positive / HER2-negative breast cancer.
Shares Celcuity, PIK3CA / PI3K-alpha, HR-positive / HER2-negative breast cancer.
Shares AKT, PIK3CA / PI3K-alpha, PI3K / AKT / mTOR, HR-positive / HER2-negative breast cancer.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, PIK3CA / PI3K-alpha, HR-positive / HER2-negative breast cancer.
Shares AKT, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, PI3K / AKT / mTOR, Small-molecule kinase inhibitors.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, PIK3CA / PI3K-alpha, HR-positive / HER2-negative breast cancer.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, HR-positive / HER2-negative breast cancer.