{"entity":{"id":"gedatolisib","kind":"drug","name":"Gedatolisib","aka":[],"tldr":"An intravenous drug that blocks the whole PI3K/mTOR pathway, approved in July 2026 for hormone-positive breast cancer.","summary":"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.","status":"approved","asOf":"2026-09-04","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Gedatolisib"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["pik3ca","akt"],"drugs":[],"companies":["celcuity"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06190899","nct05501886","nct06757634"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Revtorpyk","modality":"Small-molecule pan-PI3K/mTOR inhibitor","mechanism":"Pan-class I PI3K and mTORC1/2 inhibitor, intravenous weekly.","approvals":[{"region":"US","year":2026,"indication":"HR+/HER2- advanced breast cancer after CDK4/6 inhibitor (July 2026)"}],"mechanismSteps":["Intravenous drug distributes to tumour","Binds all class I PI3K isoforms and mTORC1/2","Pathway output is suppressed regardless of PIK3CA mutation","With CDK4/6 and ER blockade, resistant tumours regress"],"dosing":{"route":"IV infusion","schedule":"180 mg weekly, 3 weeks on 1 week off, with palbociclib and fulvestrant","modifications":"Hold for grade 3 stomatitis or hyperglycaemia","monitoring":"Glucose, oral mucosa, blood counts","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},"toxicity":[{"event":"Stomatitis"},{"event":"Neutropenia"},{"event":"Hyperglycaemia"},{"event":"Fatigue"},{"event":"Rash"},{"event":"Nausea"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2025-05","type":"designation","region":"US","note":"Breakthrough Therapy designation, PIK3CA-wild-type HR+/HER2- breast cancer after CDK4/6","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2026-07-14","type":"approval","region":"US","note":"HR+/HER2- advanced breast cancer after CDK4/6 inhibitor with palbociclib and fulvestrant (VIKTORIA-1)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally"}]},"route":"/drugs/gedatolisib/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"hr-positive-metastatic-post-cdk46","kind":"cancer","name":"HR-positive metastatic breast cancer after CDK4/6 inhibitors","route":"/cancers/hr-positive-metastatic-post-cdk46/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"akt","kind":"target","name":"AKT","route":"/targets/akt/"},{"id":"pik3ca","kind":"target","name":"PIK3CA / PI3K-alpha","route":"/targets/pik3ca/"}],"company":[{"id":"celcuity","kind":"company","name":"Celcuity","route":"/companies/celcuity/"}],"trial":[{"id":"nct06190899","kind":"trial","name":"Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer","route":"/trials/nct06190899/"},{"id":"nct05501886","kind":"trial","name":"Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)","route":"/trials/nct05501886/"},{"id":"nct06757634","kind":"trial","name":"Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)","route":"/trials/nct06757634/"}],"pathway":[{"id":"pi3k-akt-mtor","kind":"pathway","name":"PI3K / AKT / mTOR","route":"/pathways/pi3k-akt-mtor/"}],"roadmap":[{"id":"hormonal-therapy-roadmap","kind":"roadmap","name":"Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test","route":"/roadmaps/hormonal-therapy-roadmap/"}]}}