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For U.S. Healthcare Professionals

Patients with cholangiocarcinoma face a poor prognosis1,2

CCA is often advanced at presentation and is highly heterogeneous, exacerbating post-1L clinical challenges1,2

Predominantly advanced presentation1

Most patients present with locally advanced or metastatic disease due to late manifestation of clinical symptoms and resulting diagnosis delays.

Poor survival rates among patients with advanced CCA:

5-year overall survival for patients with iCCA is less than 10%

<10%: 5-year OS for patients with iCCA2

High tumor heterogeneity1

iCCA is a progressive, molecularly heterogeneous disease:

Roughly 50% of patients with CCA harbor actionable gene mutations

~50% of patients with CCA harbor actionable gene mutations1

Up to 16% of iCCAs contain FGFR genetic alterations

Up to 16% of iCCAs contain FGFR genetic alterations3

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1L=first-line; CCA=cholangiocarcinoma; FGFR=fibroblast growth factor receptor; iCCA=intrahepatic cholangiocarcinoma; OS=overall survival.

References:

1. 

Banales JM, Marin JJG, Lamarca A, et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020;17(9):557-588.

2. 

Goyal L, Konpetch S, Crolley VE, Bridgewater J. Targeting FGFR inhibition in cholangiocarcinoma. Cancer Treat Rev. 2021;95:102170.

3. 

Jain A, Borad MJ, Kelley RK, et al. Cholangiocarcinoma with FGFR genetic aberrations: a unique clinical phenotype. JCO Precis Oncol. 2018;2:1-12.

INDICATIONS AND USAGE

INDICATION AND USAGE

LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
  • Ocular Toxicity: LYTGOBI can cause Retinal Pigment Epithelial Detachment (RPED), which may cause symptoms such as blurred vision. RPED occurred in 9% of 318 patients who received LYTGOBI across clinical trials. The median time to first onset of RPED was 40 days. RPED led to dose interruption of LYTGOBI in 1.3% of patients, dose reduction in 1.6% of patients, and permanent discontinuation in 0.3% of patients. Perform a comprehensive ophthalmological examination, including optical coherence tomography (OCT) of the macula, prior to initiation of therapy, every 2 months for the first 6 months, and every 3 months thereafter. For onset of visual symptoms, refer patients for ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of LYTGOBI. Withhold or reduce the dose of LYTGOBI as recommended. Dry Eye/Corneal Keratitis: Among 318 patients who received LYTGOBI across clinical trials, dry eye occurred in 15% of patients. Treat patients with ocular demulcents as needed.
  • Hyperphosphatemia and Soft Tissue Mineralization: LYTGOBI can cause hyperphosphatemia leading to soft tissue mineralization, calcinosis, nonuremic calciphylaxis, and vascular calcification. Hyperphosphatemia was reported in 88% of 318 patients treated with LYTGOBI across clinical trials with a median time of onset of 5 days (range 3‑117). Phosphate binders were received by 77% of patients who received LYTGOBI. Monitor for hyperphosphatemia throughout treatment. Initiate a low-phosphate diet and phosphate-lowering therapy when serum phosphate level is ≥5.5 mg/dL; initiate or intensify phosphate-lowering therapy when >7 mg/dL; reduce dose, withhold, or permanently discontinue LYTGOBI based on duration and severity of hyperphosphatemia.
  • Embryo-fetal Toxicity: Based on findings in an animal study and its mechanism of action, LYTGOBI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential, and males with female partners of reproductive potential, to use effective contraception during treatment with LYTGOBI and for 1 week after the last dose.

ADVERSE REACTIONS
  • Serious adverse reactions occurred in 39% of patients receiving LYTGOBI, and in ≥2% of patients included pyrexia (3.9%), gastrointestinal hemorrhage (3.9%), ascites (2.9%), musculoskeletal pain (2.9%), and bile duct obstruction (2.9%).
  • The most common adverse reactions (≥20%) were nail toxicity (47%), musculoskeletal pain (43%), constipation (39%), diarrhea (39%), fatigue (37%), dry mouth (35%), alopecia (34%), stomatitis (30%), abdominal pain (30%), dry skin (29%), arthralgia (25%), dysgeusia (25%), dry eye (25%), nausea (24%), decreased appetite (23%), urinary tract infection (23%), palmar-plantar erythrodysesthesia syndrome (21%), and vomiting (20%).
  • The most common laboratory abnormalities (≥20%) were increased phosphate (97%), increased creatinine (58%), decreased hemoglobin (52%), increased glucose (52%), increased calcium (51%), decreased sodium (51%), decreased phosphate (50%), increased alanine aminotransferase (50%), increased alkaline phosphatase (47%), decreased lymphocytes (46%), increased aspartate aminotransferase (46%), decreased platelets (42%), increased activated partial thromboplastin time (36%), decreased leukocytes (33%), decreased albumin (31%), decreased neutrophils (31%), increased creatine kinase (31%), increased bilirubin (28%), decreased glucose (25%), increased prothrombin international normalized ratio (25%), and decreased potassium (22%).

DRUG INTERACTIONS
  • Dual P-gp and Strong CYP3A Inhibitors: Avoid concomitant use of drugs that are dual P-gp and strong CYP3A inhibitors.
  • Dual P-gp and Strong CYP3A Inducers: Avoid concomitant use of drugs that are dual P-gp and strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS
  • Lactation: Because of the potential for serious adverse reactions from LYTGOBI in breastfed children, advise women not to breastfeed during treatment and for 1 week after the last dose.
  • Hepatic Impairment: Patients with hepatic impairment may have the potential for increased adverse reactions compared to patients with normal hepatic function.

Please see accompanying full Prescribing Information for complete details.

Important Safety Information

INDICATION AND USAGE

LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
  • Ocular Toxicity: LYTGOBI can cause Retinal Pigment Epithelial Detachment (RPED), which may cause symptoms such as blurred vision. RPED occurred in 9% of 318 patients who received LYTGOBI across clinical trials. The median time to first onset of RPED was 40 days. RPED led to dose interruption of LYTGOBI in 1.3% of patients, dose reduction in 1.6% of patients, and permanent discontinuation in 0.3% of patients. Perform a comprehensive ophthalmological examination, including optical coherence tomography (OCT) of the macula, prior to initiation of therapy, every 2 months for the first 6 months, and every 3 months thereafter. For onset of visual symptoms, refer patients for ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of LYTGOBI. Withhold or reduce the dose of LYTGOBI as recommended. Dry Eye/Corneal Keratitis: Among 318 patients who received LYTGOBI across clinical trials, dry eye occurred in 15% of patients. Treat patients with ocular demulcents as needed.
  • Hyperphosphatemia and Soft Tissue Mineralization: LYTGOBI can cause hyperphosphatemia leading to soft tissue mineralization, calcinosis, nonuremic calciphylaxis, and vascular calcification. Hyperphosphatemia was reported in 88% of 318 patients treated with LYTGOBI across clinical trials with a median time of onset of 5 days (range 3‑117). Phosphate binders were received by 77% of patients who received LYTGOBI. Monitor for hyperphosphatemia throughout treatment. Initiate a low-phosphate diet and phosphate-lowering therapy when serum phosphate level is ≥5.5 mg/dL; initiate or intensify phosphate-lowering therapy when >7 mg/dL; reduce dose, withhold, or permanently discontinue LYTGOBI based on duration and severity of hyperphosphatemia.
  • Embryo-fetal Toxicity: Based on findings in an animal study and its mechanism of action, LYTGOBI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential, and males with female partners of reproductive potential, to use effective contraception during treatment with LYTGOBI and for 1 week after the last dose.

ADVERSE REACTIONS
  • Serious adverse reactions occurred in 39% of patients receiving LYTGOBI, and in ≥2% of patients included pyrexia (3.9%), gastrointestinal hemorrhage (3.9%), ascites (2.9%), musculoskeletal pain (2.9%), and bile duct obstruction (2.9%).
  • The most common adverse reactions (≥20%) were nail toxicity (47%), musculoskeletal pain (43%), constipation (39%), diarrhea (39%), fatigue (37%), dry mouth (35%), alopecia (34%), stomatitis (30%), abdominal pain (30%), dry skin (29%), arthralgia (25%), dysgeusia (25%), dry eye (25%), nausea (24%), decreased appetite (23%), urinary tract infection (23%), palmar-plantar erythrodysesthesia syndrome (21%), and vomiting (20%).
  • The most common laboratory abnormalities (≥20%) were increased phosphate (97%), increased creatinine (58%), decreased hemoglobin (52%), increased glucose (52%), increased calcium (51%), decreased sodium (51%), decreased phosphate (50%), increased alanine aminotransferase (50%), increased alkaline phosphatase (47%), decreased lymphocytes (46%), increased aspartate aminotransferase (46%), decreased platelets (42%), increased activated partial thromboplastin time (36%), decreased leukocytes (33%), decreased albumin (31%), decreased neutrophils (31%), increased creatine kinase (31%), increased bilirubin (28%), decreased glucose (25%), increased prothrombin international normalized ratio (25%), and decreased potassium (22%).

DRUG INTERACTIONS
  • Dual P-gp and Strong CYP3A Inhibitors: Avoid concomitant use of drugs that are dual P-gp and strong CYP3A inhibitors.
  • Dual P-gp and Strong CYP3A Inducers: Avoid concomitant use of drugs that are dual P-gp and strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS
  • Lactation: Because of the potential for serious adverse reactions from LYTGOBI in breastfed children, advise women not to breastfeed during treatment and for 1 week after the last dose.
  • Hepatic Impairment: Patients with hepatic impairment may have the potential for increased adverse reactions compared to patients with normal hepatic function.

Please see accompanying full Prescribing Information for complete details.