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NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Recommendations for Cholangiocarcinoma

Futibatinib (LYTGOBI) is recommended as a National Comprehensive Cancer Network® (NCCN®) subsequent-line systemic therapy option for unresectable or metastatic intrahepatic or extrahepatic cholangiocarcinoma with FGFR2 fusions or rearrangements if disease progression1*†

Sample‡ treatment algorithm for subsequent-line use for CCA with FGFR2 fusions or rearrangements:

Primary Therapy for Unresectable
and Metastatic Disease

Subsequent-Line Therapy
if Disease Progression

Durvalumab +
gemcitabine + cisplatin

Futibatinib (LYTGOBI)

*NCCN Category 2A recommendation: based upon lower-level evidence, there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.
†Treatment selection depends on clinical factors, including previous treatment regimen/agent, somatic molecular testing results, and extent of liver dysfunction.
‡These treatment algorithms are examples only; other treatment options are recommended in the NCCN Guidelines.

LYTGOBI demonstrated an overall response rate (ORR) of 42% in patients with previously treated locally advanced or metastatic iCCA2

ORR: 42%

LYTGOBI demonstrated 42% overall response rate in patients with previously treated locally advanced or metastatic cholangiocarcinoma

2.5 months median time to response
(range: 0.7-7.4)

The ORR for LYTGOBI was

42%

(95% CI: 32%, 52%)

  • PR: 42%

Patients experienced a median duration of response (mDoR) of nearly 10 months with LYTGOBI2

Median DoR

9.7

Months

(95% CI: 7.6-17.1)

72%
of responders (n=31)
had responses that
lasted ≥6 months

14%
of responders (n=6)
had responses that
lasted ≥1 year

phase-trial

See how LYTGOBI was studied in a clinical trial
LYTGOBI® (futibatinib) safety profile icon

View the safety profile of LYTGOBI
pill

Learn about LYTGOBI dosing

CI=confidence interval; DoR=duration of response; iCCA=intrahepatic cholangiocarcinoma; PR=partial response.

References:

1. 

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Biliary Tract Cancers. V.4.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed September 10, 2024. 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.

2. 

LYTGOBI [package insert]. Princeton, NJ: Taiho Oncology, Inc.; 2024.

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.