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REVTORPYK is indicated in combination with fulvestrant ± palbociclib, for your patients with HR+/HER2-, PIK3CA wild-type advanced breast cancer (aBC) or metastatic breast cancer (mBC) following progression on or after ≥1 line of ET in the metastatic setting1

NOW AVAILABLE!

REVTORPYK is

Built to
Block

  • BLOCK the key targets of the PI3K/AKT/mTOR (PAM) pathway with REVTORPYK1*
  • BLOCK the key drivers of progression—
    PAM, ER, CDK4/6—with the REVTORPYK triplet regimen1–6

*REVTORPYK is a kinase inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2, resulting in downstream inhibition of multiple effectors, including AKT.1

Median progression-free survival (primary endpoint)1

>4.5X mPFS

9.3 months with the REVTORPYK triplet
vs 2.0 months with fulvestrant alone
(HR=0.24; 95% CI: 0.17–0.35; P<0.0001)

*REVTORPYK is a kinase inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2, resulting in downstream inhibition of multiple effectors, including AKT.1

  • NCCN CATEGORY 1
    PREFERRED
  • NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer recommend gedatolisib (Revtorpyk) and fulvestrant ± palbociclib as a Category 1 treatment option for 2L in certain patients with PIK3CA wild-type, HR+/HER2- metastatic breast cancer or advanced breast cancer7

First and only

REVTORPYK is the first and only comprehensive PAM pathway inhibitor for the treatment of HR+/HER2-, PIK3CA wild-type aBC or mBC.1,8,9

Learn about the blocking power of REVTORPYK

Clinically meaningful efficacy

9.3 months mPFS with the REVTORPYK triplet vs 2.0 months with fulvestrant alone (HR=0.24; 95% CI: 0.17-0.35; P<0.0001).1

Explore the efficacy of REVTORPYK

Established safety profile

The majority of ARs in patients receiving REVTORPYK regimens in the VIKTORIA-1 trial were grade 1 or 2.10

See safety profile
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The efficacy and safety of REVTORPYK plus fulvestrant, with or without palbociclib, was evaluated in VIKTORIA-1 study 1, a phase 3, open-label, randomized, multicenter clinical trial that enrolled 392 patients with locally advanced (inoperable) or metastatic HR+, HER2- (defined as immunohistochemistry [IHC] 0 or 1+, or IHC 2+/in situ hybridization [ISH-]), PIK3CA wild-type (no detectable mutations) breast cancer. All patients were required to have progression on or after treatment with a CDK4/6i and a nonsteroidal AI therapy. Patients could have received up to 2 prior lines of ET for locally advanced (inoperable) or metastatic disease. The major efficacy outcome was comparison of PFS assessed by BICR and evaluated according to RECIST version 1.1. Additional efficacy outcome measures were OS, ORR, and DOR.1,10

2L=second line; AI=aromatase inhibitor; AKT=protein kinase B; AR=adverse reaction; BICR=blinded independent central review; CDK4/6=cyclin-dependent kinases 4 and 6; CDK4/6i=cyclin-dependent kinases 4 and 6 inhibitor; DOR=duration of response; ER=estrogen receptor; ET=endocrine therapy; HER2-=human epidermal growth factor receptor 2 negative; HR=hazard ratio; HR+=hormone receptor positive; mPFS=median progression-free survival; mTOR=mammalian target of rapamycin; mTORC1=mammalian target of rapamycin complex 1; mTORC2=mammalian target of rapamycin complex 2; NCCN=National Comprehensive Cancer Network; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PI3K=phosphoinositide 3-kinase; PIK3CA=phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; RECIST=Response Evaluation Criteria in Solid Tumors.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Stomatitis: REVTORPYK can cause severe stomatitis, including ulcers and oral mucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK with fulvestrant and palbociclib, including Grade 3 events in 22% of patients. Stomatitis occurred in 58% of patients treated with REVTORPYK with fulvestrant, including Grade 3 events in 12% of patients. Initiate a steroid-containing, alcohol-free mouthwash prior to starting treatment with REVTORPYK and continue prophylactically during treatment. Monitor patients for signs and symptoms of stomatitis. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Dermatologic Adverse Reactions: REVTORPYK can cause severe rash. Rash occurred in 30% of patients treated with REVTORPYK in combination with fulvestrant and palbociclib, including Grade 3 events in 6% of patients. Rash occurred in 40% of patients treated with REVTORPYK with fulvestrant, including 5% of patients with Grade 3 events. Monitor patients for rash and infectious sequelae. Instruct patients to limit sun exposure during REVTORPYK treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Hyperglycemia: REVTORPYK can cause severe hyperglycemia. Monitor fasting glucose prior to initiating treatment with REVTORPYK and periodically during treatment. Monitor HbA1c level if clinically indicated. Increased fasting glucose occurred in 46% of patients receiving REVTORPYK in combination with fulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving REVTORPYK in combination with fulvestrant (Grade 3: 1.8%). The safety of REVTORPYK has not been established in patients with Type 1 or uncontrolled Type 2 diabetes mellitus. Patients with well-controlled Type 2 diabetes may require intensified antihyperglycemic therapy and close monitoring of fasting glucose. Manage hyperglycemia with antihyperglycemic medications as clinically indicated. Evaluate fasting blood glucose and HbA1c levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Embryo-Fetal Toxicity: Based on its mechanism of action, REVTORPYK can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with REVTORPYK and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose.

Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When REVTORPYK is used in combination, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Verify the pregnancy status of females of reproductive potential prior to initiating treatment.

ADVERSE REACTIONS

REVTORPYK in Combination with Fulvestrant and Palbociclib: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant and palbociclib were decreased white blood cells, decreased neutrophils, decreased hemoglobin, decreased lymphocytes, stomatitis, nausea, decreased platelets, increased fasting glucose, fatigue, vomiting, rash, constipation, diarrhea, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), musculoskeletal pain, decreased sodium, and increased eosinophils.

REVTORPYK in Combination with Fulvestrant: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant were stomatitis, glucose increased, eosinophils increased, hemoglobin decreased, nausea, rash, ALT increased, fatigue, musculoskeletal pain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea.

INDICATION AND USAGE

REVTORPYK is a kinase inhibitor 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.

INDICATION AND USAGE

REVTORPYK is a kinase inhibitor 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.

Please see the full Prescribing Information for REVTORPYK.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Celcuity at 877-4-CELCUITY (877-423-5284).

References: 1. Revtorpyk. Prescribing information. Celcuity Inc; 2026. 2. Liu L, Graff SL, Wang Y. New emerging therapies targeting PI3K/AKT/mTOR/PTEN pathway in hormonal receptor-positive and HER2-negative breast cancer—current state and molecular pathology perspective. Cancers (Basel). 2024;17(1):16. 3. Clusan L, Ferrière F, Flouriot G, Pakdel F. A basic review on estrogen receptor signaling pathways in breast cancer. Int J Mol Sci. 2023;24(7):6834. 4. Finn RS, Aleshin A, Slamon DJ. Targeting the cyclin-dependent kinases (CDK) 4/6 in estrogen receptor-positive breast cancers. Breast Cancer Res. 2016;18(1):17. 5. Ibrance. Prescribing information. Pfizer Inc; 2025. 6. Faslodex. Prescribing information. AstraZeneca Pharmaceuticals LP; 2020. 7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.6.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed July 29, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 8. Broege A, Rossetti S, Sen A, et al. Functional analysis of the PI3K/AKT/mTOR pathway inhibitor, gedatolisib, plus fulvestrant with and without palbociclib in breast cancer models. Int J Mol Sci. 2025;26(12):5844. 9. Rossetti S, Broege A, Sen A, et al. Gedatolisib shows superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ Breast Cancer. 2024;10(1):40. 10. Hurvitz SA, Layman RM, Curigliano G, et al. VIKTORIA-1 trial of gedatolisib plus fulvestrant with or without palbociclib in hormone receptor-positive/HER2-/PIK3CA wild-type advanced breast cancer. J Clin Oncol. 2026;44(12):1108-1119.