medcelerator · clinician one-pager
New IV Treatment for Advanced Hormone-Positive Breast Cancer
Revtorpyk (gedatolisib) — IV pan-PI3K/mTOR inhibitor for HR+/HER2−, PIK3CA-wild-type advanced breast cancer
FDA Approved · United States · September 7, 2026
Condition: Breast Cancer
Who this is for
Revtorpyk is a US-labelled IV pan-PI3K / mTOR inhibitor used with fulvestrant, with or without palbociclib, for adults whose HR+/HER2− advanced breast cancer has no detectable PIK3CA mutation after at least one metastatic endocrine line. It may help when progression after CDK4/6 + aromatase-inhibitor therapy leaves limited endocrine options and PIK3CA-targeted drugs do not fit. In practice, access today is through a US oncology infusion chair on a 3-weeks-on / 1-week-off schedule — not a DIY import, not a confirmed licence outside the United States, and not the same path as oral Veppanu for ESR1-mutated disease.
Next clinical step
The US Food and Drug Administration (FDA) has approved this medicine. In the United States, ask your doctor or a specialist whether it suits you. They can write a prescription. Insurance or public drug plan coverage is not guaranteed.
Ways to access this treatment
United States · Prescription
US prescription (FDA-labelled)
https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=959d73ef-831f-4005-956c-210702270bda
United States · Recruiting clinical trial
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
Combination or different setting. Gedatolisib + palbociclib with fulvestrant or letrozole in the first-line setting (phase 3).
https://clinicaltrials.gov/study/NCT06757634
See 1 trial on ClinicalTrials.gov: https://clinicaltrials.gov/search?cond=breast%20cancer&intr=gedatolisib&aggFilters=status:rec
General resources for further research
ClinicalTrials.gov
US National Library of Medicine registry of clinical studies. Search by condition, drug, NCT number, and location. A listing is not enrolment, eligibility, or funding. Talk with the trial contact and a clinician before assuming a slot exists.
https://clinicaltrials.gov/
AI-produced discussion aid; not prescribing instructions. Approval does not establish coverage. Full article: https://medcelerator.com/articles/revtorpyk-gedatolisib