Prescription medicine
Gedatolisib Brand names: Revtorpyk
Gedatolisib (Revtorpyk) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the gedatolisib FDA label on DailyMed (effective July 14, 2026, Celcuity Inc.); the NDA 219908 record on Drugs@FDA; every gedatolisib label on DailyMed.
Highlights of the record
FDA label of July 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageREVTORPYK is indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative 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 [see Dosage
Forms and strengths
- 180 mg
Injection (powder) for solution.
On the market
- Earliest approval on file
- July 14, 2026 Revtorpyk, Celcuity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is gedatolisib used for?
From the label: indications and usageREVTORPYK is indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative 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 [see Dosage and Administration (2.1) and Clinical Studies (14) ]. […]
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (REVTORPYK), Celcuity Inc., effective July 14, 2026 (SPL set 959d73ef-831f-4005-956c-210702270bda), via openFDA; the full label on DailyMed
Is there a generic for gedatolisib (Revtorpyk)?
No generic gedatolisib is approved (Drugs@FDA, October 8, 2026).
- 2026 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the gedatolisib label say about other medicines?
The gedatolisib label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fulvestrant | warnings and precautions | In Study 1 of VIKTORIA-1, increased fasting glucose (FG) from baseline occurred in 46% of patients treated with REVTORPYK in combination with fulvestrant and palbociclib, including Grade 1 (FG >ULN to 160 mg/dL) in 36% of patients, Grade 2 (FG >160 to 250 mg/dL) in 8% of patients and Grade 3 (FG >250 to 500 mg/dL) in … |
| Palbociclib | warnings and precautions | In Study 1 of VIKTORIA-1, increased fasting glucose (FG) from baseline occurred in 46% of patients treated with REVTORPYK in combination with fulvestrant and palbociclib, including Grade 1 (FG >ULN to 160 mg/dL) in 36% of patients, Grade 2 (FG >160 to 250 mg/dL) in 8% of patients and Grade 3 (FG >250 to 500 mg/dL) in … |
Source: FDA drug label (REVTORPYK), Celcuity Inc., effective July 14, 2026 (SPL set 959d73ef-831f-4005-956c-210702270bda), via openFDA; the full label on DailyMed
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other