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For U.S. Healthcare Professionals

FOENIX-CCA2: Established safety with LYTGOBI1

Safety considerations reported in FOENIX-CCA2

  • Among the most common (≥15%) ARs experienced by patients receiving LYTGOBI in FOENIX-CCA2, no Grade 4 or 5 reactions occurred
  • Clinically relevant ARs occurring in ≤15% of patients included retinal pigment epithelial detachment (RPED, 7.8%)
  • Use of LYTGOBI is associated with the following serious risks: ocular toxicity, hyperphosphatemia and soft tissue mineralization, and embryo-fetal toxicity

Adverse reactions in ≥15% of patients receiving LYTGOBI in the phase 2 portion of the FOENIX-CCA2 trial

LYTGOBI (N=103)
Adverse reaction All gradesa
(%)		 Grade 3
(%)
Skin and subcutaneous tissue disorders
Nail toxicityb 47 1.9
Alopecia 34 0
Dry skin 29 0
Palmar-plantar
erythrodysesthesia
syndrome		 21 4.9
Gastrointestinal disorders
Constipation 39 0
Diarrheac 39 1
Dry mouth 35 0
Stomatitisd 30 6
Abdominal paine 30 2.9
Nausea 24 1.9
Vomitingf 20 1
General disorders
Fatigueg 37 8
Metabolism and nutrition disorders
Decreased appetite 23 2.9
Musculoskeletal and connective tissue disorders
Musculoskeletal painh 43 3.9
Arthralgiai 25 0
Eye disorders
Dry eyej 25 1
Nervous system disorders
Dysgeusiak 25 0
Infections
Urinary tract infectionl 23 2.9
Investigations
Weight decreased 18 3.9
  • aGraded per NCI CTCAE 4.03.
  • bIncludes nail toxicity, nail disorder, nail discoloration, nail dystrophy, nail hypertrophy, nail infection, nail pigmentation, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomycosis, and paronychia.
  • cIncludes diarrhea, colitis, and gastroenteritis.
  • dIncludes stomatitis, glossitis, mouth ulceration, mucosal inflammation, pharyngeal inflammation, and tongue ulceration.
  • eIncludes abdominal pain, abdominal discomfort, abdominal pain upper, gastrointestinal pain, and hepatic pain.
  • fIncludes vomiting and hematemesis.
  • gIncludes fatigue and asthenia.
  • hIncludes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, non-cardiac chest pain, pain in extremity, and spinal pain.
  • iIncludes arthralgia and arthritis.
  • jIncludes dry eye, keratitis, lacrimation increased, photokeratitis, punctate keratitis, and ulcerative keratitis.
  • kIncludes dysgeusia, ageusia, and taste disorder.
  • lIncludes urinary tract infection, cystitis, and dysuria.

Select laboratory abnormalities worsening from baseline in ≥10% of patients receiving LYTGOBI

LYTGOBI (N=103)
Laboratory Abnormalitym All gradesn
(%)		 Grades 3 or 4
(%)
Hematology
Decreased
hemoglobin		 52 6
Decreased
lymphocytes		 46 10
Decreased
platelets		 42 1
Decreased
leukocytes		 33 1.1
Decreased
neutrophils		 31 1.6
Chemistry
Increased
phosphateo		 97 39
Increased
creatininep		 58 0
Increased
glucose		 52 4.9
Increased
calcium		 51 1.2
Decreased
sodium		 51 15
Decreased
phosphate		 50 20
Increased
alanine
aminotrans-
ferase		 50 7
Increased
alkaline phosphatase		 47 4.9
Increased
aspartate
aminotrans-
ferase		 46 13
Decreased
albumin		 31 2.4
Increased
creatine kinase		 31 5
Increased
bilirubin		 28 0
Decreased
glucose		 25 0
Decreased
potassium		 22 2.1
Increased
potassium		 16 2
Coagulation
Increased
activated
partial
thromboplastin
time		 36 8
Increased
prothrombin
international
normalized ratio		 25 0
  • mGraded per NCI CTCAE 4.03.
  • nPercentages are based on patients with data at both baseline and at least one relevant post-baseline data value.
  • oNCI CTCAE 4.03 does not define grades for increased phosphate. Laboratory value shift table categories were used to assess increased phosphorus levels (Grades ≥3 defined as >7 mg/dL).
  • pGraded based on comparison to upper limit of normal.
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AR=adverse reaction; CTCAE=Common Terminology Criteria for Adverse Events; NCI=National Cancer Institute.

References:

1. 

LYTGOBI [package insert]. Princeton, NJ: Taiho Oncology, Inc.; 2022.

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, gastrointestinal hemorrhage, ascites, musculoskeletal pain, and bile duct obstruction.
  • The most common adverse reactions (≥20%) were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting.
  • The most common laboratory abnormalities (≥20%) were increased phosphate, increased creatinine, decreased hemoglobin, increased glucose, increased calcium, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocytes, increased aspartate aminotransferase, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, decreased glucose, increased prothrombin international normalized ratio, and decreased potassium.

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.

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, gastrointestinal hemorrhage, ascites, musculoskeletal pain, and bile duct obstruction.
  • The most common adverse reactions (≥20%) were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting.
  • The most common laboratory abnormalities (≥20%) were increased phosphate, increased creatinine, decreased hemoglobin, increased glucose, increased calcium, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocytes, increased aspartate aminotransferase, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, decreased glucose, increased prothrombin international normalized ratio, and decreased potassium.

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.

Please see accompanying full Prescribing Information for complete details.