GAVRETO was generally well tolerated in patients with RET+ mNSCLC1

mNSCLC=metastatic non–small cell lung cancer; RET+=rearranged during transfection positive.

Safety of GAVRETO was evaluated in 220 patients with RET+ mNSCLC in ARROW1


of patients permanently discontinued GAVRETO
due to any adverse reaction1


discontinued due to adverse reactions considered treatment-related by the trial investigator33

Adverse reactions resulting in permanent discontinuation which occurred in >1 patient included pneumonitis (1.8%), pneumonia (1.8%), and sepsis (1%).

Dose modifications and interruptions in RET fusion+ mNSCLC1

Dose reductions due to an adverse reaction occurred in 36% of patients treated with GAVRETO

Adverse reactions requiring dosage reductions in ≥2% of patients included neutropenia, anemia, pneumonitis, neutrophil count decreased, fatigue, hypertension, pneumonia, and leukopenia.

Dosage interruptions due to an adverse reaction occurred in 60% of patients treated with GAVRETO

Adverse reactions requiring dosage interruption in ≥2% of patients included neutropenia, pneumonitis, anemia, hypertension, pneumonia, pyrexia, increased aspartate aminotransferase (AST), increased blood creatine phosphokinase, fatigue, leukopenia, thrombocytopenia, vomiting, increased alanine aminotransferase (ALT), sepsis, and dyspnea.

Adverse reactions (≥15%) in RET fusion-positive mNSCLC patients who received GAVRETO in ARROW

Adverse Reactions GAVRETO (N=220)
Grades 1-4 (%) Grades 3-4 (%)
Fatigue* 35 2.3**
Pyrexia 20 0
Edema 20 0
Constipation 35 1**
Diarrhea 24 3.2**
Dry Mouth 16 0
Musculoskeletal Disorders
Musculoskeletal Pain§ 32 0
Hypertension|| 28 14**
Respiratory, thoracic, and mediastinal
Cough 23 0.5**
Pneumonia# 17 8

*Fatigue includes fatigue, asthenia.
Edema includes edema peripheral, face edema, periorbital edema, eyelid edema, edema generalized, swelling.
Diarrhea includes diarrhea, colitis, enteritis.
§Musculoskeletal pain includes back pain, myalgia, arthralgia, pain in extremity, musculoskeletal pain, neck pain, musculoskeletal chest pain, bone pain, musculoskeletal stiffness, arthritis, spinal pain.
||Hypertension includes hypertension, blood pressure increased.
Cough includes cough, productive cough, upper-airway cough syndrome.
#Pneumonia includes pneumonia, atypical pneumonia, lung infection, pneumocystis jirovecii pneumonia, pneumonia bacterial, pneumonia cytomegaloviral, pneumonia haemophilus, pneumonia influenza, pneumonia streptococcal.
**Only includes a Grade 3 adverse reaction.

Select laboratory abnormalities (≥20%) worsening from baseline in RET fusion-positive mNSCLC patients who received GAVRETO in ARROW

GAVRETO showed Grades 3-4 AST/ALT elevations of 2.3%

Laboratory Abnormality†† GAVRETO (N=220)
Grades 1-4 (%) Grades 3-4 (%)
Increased aspartate aminotransferase (AST) 74 2.3
Increased alanine aminotransferase (ALT) 49 2.3
Increased alkaline phosphatase 42 1.8
Decreased calcium (corrected) 39 1.8
Decreased albumin 36 0
Decreased phosphate 35 11
Increased creatinine 33 0.5
Decreased sodium 29 7
Increased potassium 26 0.9
Decreased neutrophils 61 16
Decreased hemoglobin 58 9
Decreased lymphocytes 56 19
Decreased platelets 27 3.2

††Denominator for each laboratory parameter is based on the number of patients with a baseline and post-treatment laboratory value available, which ranged from 216 to 218 patients.
Clinically relevant laboratory abnormalities in <20% of patients who received GAVRETO included increased phosphate (10%).

Adverse reactions (≥15%) and Grades 3-4 laboratory abnormalities (≥2%) in RET fusion-positive mNSCLC patients within the exploratory follow-up analyses were generally consistent with the pivotal data included in the U.S. Prescribing Information (USPI)1,33