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Treatment was generally well-tolerated, with most ARs reported as grade 1 or 2¹

  • REVTORPYK triplet
  • REVTORPYK doublet

25% experienced a serious AR²*

Serious ARs in ≥1% of patients included pneumonia (3.8%), thrombosis (3.8%), and stomatitis (1.5%).²

12% discontinued due to an AR²

ARs leading to discontinuation of REVTORPYK were stomatitis (3.8%), nausea, rash (0.8%), pneumonitis, diplopia, hypertension, vomiting, breast ulceration, and squamous cell carcinoma of the lung.²

41% experienced ARs requiring dosage reduction²

ARs requiring dose reduction of REVTORPYK in ≥2% of patients included stomatitis, neutropenia, rash, nausea, and AST or ALT increased.²

Grading refers to the severity of event.3

*Note: A serious AR refers to the outcome of the event, and includes death, a life-threatening event, hospitalization (initial or prolonged), disability, permanent damage, congenital anomaly or birth defect, required intervention, or another medically important event.4

  • Among patients receiving REVTORPYK + fulvestrant + palbociclib, 2.3% permanently discontinued all three therapies. 12% permanently discontinued REVTORPYK alone due to ARs1,2
  • No dose reductions or discontinuations of REVTORPYK were due to hyperglycemia5

ARs (≥10%) in patients who received the REVTORPYK triplet in VIKTORIA-1²

REVTORPYK triplet
(n=130)		 Fulvestrant
(n=123)
AR (%) All grades Grade 3 or 4† All grades Grade 3 or 4†
Gastrointestinal disorders
Stomatitis* 72 22 2.4 0
Nausea 51 3.8 13 0.8
Vomiting 35 1.5 4.1 0
Diarrhea* 26 1.5 4.9 0
Constipation 26 0 3.3 0
Abdominal pain* 13 0 8 4.1
General disorders and administration site conditions
Fatigue* 43 2.3 13 0.8
Pyrexia 14 0 1.6 0
Mucosal dryness* 11 0 1.6 0
Skin and subcutaneous tissue disorders
Rash* 30 6 0 0
Pruritus 19 0.8 1.6 0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain* 24 0.8 24 2.4
Nervous system disorders
Dysgeusia* 19 0 0.8 0
Dizziness* 10 0 3.3 0
Metabolism and nutrition disorders
Decreased appetite 19 0.8 4.1 0.8
Infections and infestations
Urinary tract infection* 13 0 4.1 0
Respiratory, thoracic, and mediastinal disorders
Cough* 11 0 7 0
Vascular disorders
Thrombosis* 10 3.1 0 0
Learn more about ARs

Grading according to CTCAE 5.0.²

*Includes multiple related terms.²

†No grade 4 events were reported.²

ALT=alanine aminotransferase; AST=aspartate aminotransferase; CTCAE=Common Terminology Criteria for Adverse Events.

19% experienced a serious AR²*

Serious ARs in ≥1% of patients included pneumonia (3.8%), thrombosis (2.3%), pleural effusion (1.5%), and pneumonitis (1.5%).²

9% discontinued due to an AR²

ARs leading to discontinuation of REVTORPYK were stomatitis (1.5%), nausea, rash (0.8%), pneumonitis, acute respiratory failure, myocarditis, angina pectoris, fatigue, infusion-related reaction, peripheral neuropathy, and oral pain.²

22% experienced ARs requiring dosage reduction²

ARs requiring dose reduction of REVTORPYK in ≥2% of patients included stomatitis, rash, and nausea.²

Grading refers to the severity of event.3

*Note: A serious AR refers to the outcome of the event, and includes death, a life-threatening event, hospitalization (initial or prolonged), disability, permanent damage, congenital anomaly or birth defect, required intervention, or another medically important event.4

  • Among patients receiving REVTORPYK + fulvestrant, 3.1% permanently discontinued both therapies. 9% permanently discontinued REVTORPYK alone due to ARs1,2
  • No dose reductions or discontinuations of REVTORPYK were due to hyperglycemia5

ARs (≥10%) in patients who received the REVTORPYK doublet in VIKTORIA-1²

REVTORPYK doublet
(n=130)		 Fulvestrant
(n=123)
AR (%) All grades Grade 3 or 4† All grades Grade 3 or 4†
Gastrointestinal disorders
Stomatitis* 58 12 2.4 0
Nausea 44 0.8 13 0.8
Vomiting 24 0 4.1 0
Diarrhea* 20 1.5 4.9 0
Constipation 16 0 3.3 0
Abdominal pain* 9 0 8 4.1
General disorders and administration site conditions
Fatigue* 34 0.8 13 0.8
Pyrexia 10 0 1.6 0
Mucosal dryness* 10 0 1.6 0
Skin and subcutaneous tissue disorders
Rash* 40 5 0 0
Pruritus 22 0 1.6 0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain* 26 3.1 24 2.4
Nervous system disorders
Dysgeusia* 17 0 0.8 0
Dizziness* 9 0 3.3 0
Metabolism and nutrition disorders
Decreased appetite 11 0.8 4.1 0.8
Infections and infestations
Urinary tract infection* 15 0 4.1 0
Respiratory, thoracic, and mediastinal disorders
Cough* 18 0 7 0
Vascular disorders
Thrombosis* 3.1 2.3 0 0
Learn more about ARs

Grading according to CTCAE 5.0.²

*Includes multiple related terms.²

†No grade 4 events were reported.²

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. 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. 2. Revtorpyk. Prescribing information. Celcuity Inc; 2026. 3. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v6.0. Accessed June 6, 2026. https://dctd.cancer.gov/research/ctep-trials/for-sites/adverse-events/ctcae-v6.pdf 4. U.S. Food & Drug Administration (FDA). What is a serious adverse event? Accessed June 6, 2026. https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event 5. Pistilli B, Layman RM, Curigliano G, et al. Gedatolisib, a multitarget PI3K/AKT/mTOR inhibitor, plus fulvestrant with or without palbociclib for second-line treatment of patients with HR+/HER2-/PIK3CA-WT advanced breast cancer: updated results from the randomized, phase 3 VIKTORIA-1 trial. Presented at: San Antonio Breast Cancer Symposium; December 9-12, 2025; San Antonio, TX.