Revtorpyk Approved for HR+ HER2- Advanced Breast Cancer
On July 14, 2026, the US Food and Drug Administration (FDA) approved Celcuity’s Revtorpyk™ (gedatolisib – Celcuity) in combination with fulvestrant, with or without palbociclib, for the treatment of adults who have hormone receptor-positive (HR+), human epidermal growth factor receptor 2–negative (HER2−), phosphoinositide 3-kinase (PI3K)CA wild-type locally advanced or metastatic breast cancer, without a phosphoinositide 3-kinase (PIK3)CA mutation detected, whose disease has progressed following at least one line of endocrine therapy in the metastatic setting. Revtorpyk is the first approved multi-target PI3K and mechanistic target of rapamycin (mTOR) inhibitor specifically indicated for patients with PIK3CA wild-type HR+/HER2- advanced breast cancer, a population for whom currently approved PI3Kα-targeted therapies are not indicated. It is designed to provide comprehensive blockade of the PI3K/AKT/mTOR signaling pathway, a key driver of endocrine resistance in breast cancer, as it inhibits all four class 1 PI3K isoforms (PIK3CA, PIK3CB, PIK3CD, and PIK3CG) and mTOR to help minimize the potential development of drug resistance. The recommended dose is 180mg administered intravenously (IV) once weekly on days one, eight, and 15 of each 28-day cycle. Pricing has not yet been announced. Celcuity anticipates a commercial launch in late Q3 2026. Full prescribing information can be found here.
At a Glance
- Brand Drug: Revtorpyk™ (gedatolisib)
- Manufacturer: Celcuity
- Date Approved: July 14, 2026
- Indication: In combination with fulvestrant, with or without palbociclib, for adults with HR+/ HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
- Dosage Forms Available: Single-dose vials containing 180mg of gedatolisib as a lyophilized powder
- Launch Date: Expected late in quarter three 2026.
- Estimated Annual Cost: TBD
- FDA Designation: Breakthrough Therapy. Priority Review. Fast Track. Real-Time Oncology Review (RTOR).
- HR+ /HER2- breast cancer represents the most common subtype of breast cancer, accounting for approximately 70% of breast cancer cases. Approximately 60% of these patients have PIK3CA wild type tumors.
- Approval was supported by the phase III VIKTORIA-1 trial, in which Revtorpyk plus fulvestrant and palbociclib reduced the risk of disease progression or death by 76% versus fulvestrant alone, while Revtorpyk plus fulvestrant reduced the risk by 67%. Objective response rates were 32% with the triplet regimen, 28% with the doublet regimen, and 1% with fulvestrant alone.
- The prescribing information includes warnings and precautions for stomatitis, dermatologic adverse reactions, hyperglycemia, and embryo-fetal toxicity.
- Revtorpyk will compete with existing endocrine- and PI3K-pathway-based therapies used after progression on endocrine treatment, including Piqray® (alpelisib) for patients with PIK3CA-mutated disease, as well as fulvestrant-based regimens, CDK4/6 inhibitor combinations, and emerging oral selective estrogen receptor degraders (SERDs) in development for HR+, HER2- advanced breast cancer
- Celcuity plans to submit a supplemental New Drug Application (sNDA) in Q3 2026 for patients with HR+, HER2-, PIK3CA-mutated locally advanced or metastatic breast cancer, and the drug is also being evaluated in treatment-naïve patients with advanced HR+/HER2-negative breast cancer. Revtorpyk is also being evaluated in other tumor types, including metastatic castration-resistant prostate cancer.
- While commercial launch is anticipated in late Q3 2026, eligible patients may gain access to therapy earlier through Celcuity’s expanded access program.