RET+=rearranged during transfection positive.
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 fatigue, pneumonia, and anemia.
Dose reductions due to an adverse reaction occurred in 44% of patients treated with GAVRETO
Adverse reactions requiring dosage reductions in ≥2% of patients included neutropenia, anemia, hypertension, increased blood creatine phosphokinase, decreased lymphocyte count, pneumonitis, fatigue, and thrombocytopenia.
Dosage interruptions due to an adverse reaction occurred in 67% of patients treated with GAVRETO
Adverse reactions requiring dosage interruption in ≥2% of patients included neutropenia, hypertension, diarrhea, fatigue, pneumonitis, anemia, increased blood creatine phosphokinase, pneumonia, urinary tract infection, musculoskeletal pain, vomiting, pyrexia, increased AST, dyspnea, hypocalcemia, cough, thrombocytopenia, abdominal pain, increased blood creatinine, dizziness, headache, decreased lymphocyte count, stomatitis, and syncope.
Adverse Reactions | GAVRETO (N=138) | |
Grades 1-4 (%) | Grades 3-4 (%) | |
Musculoskeletal | ||
Musculoskeletal pain* | 42 | 0.7## |
Gastrointestinal | ||
Constipation | 41 | 0.7## |
Diarrhea† | 34 | 5## |
Abdominal pain‡ | 17 | 0.7## |
Dry Mouth | 17 | 0 |
Stomatitis§ | 17 | 0.7## |
Nausea | 17 | 0.7## |
Vascular | ||
Hypertension | 40 | 21## |
General | ||
Fatigue|| | 38 | 6## |
Edema¶ | 29 | 0 |
Pyrexia | 22 | 2.2## |
Nervous system | ||
Headache# | 24 | 0 |
Peripheral neuropathy** | 20 | 0 |
Dizziness†† | 19 | 0.7## |
Dysgeusia‡‡ | 17 | 0 |
Respiratory | ||
Cough§§ | 27 | 1.4## |
Dyspnea|||| | 22 | 2.2## |
Skin and subcutaneous | ||
Rash¶¶ | 24 | 0 |
Metabolism and nutrition | ||
Decreased appetite | 15 | 0 |
*Musculoskeletal pain includes arthralgia, arthritis, back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, non-cardiac chest pain, pain in extremity, spinal pain.
†Diarrhea includes colitis, diarrhea.
‡Abdominal pain includes abdominal discomfort, abdominal pain, abdominal pain upper, abdominal tenderness, epigastric discomfort.
§Stomatitis includes mucosal inflammation, stomatitis, tongue ulceration.
||Fatigue includes asthenia, fatigue.
¶Edema includes eyelid edema, face edema, edema, edema peripheral, periorbital edema.
#Headache includes headache, migraine.
**Peripheral neuropathy includes dysaesthesia, hyperaesthesia, hypoaesthesia, neuralgia, neuropathy peripheral, paraesthesia, peripheral sensory neuropathy, polyneuropathy.
††Dizziness includes dizziness, dizziness postural, vertigo.
‡‡Dysgeusia includes ageusia, dysgeusia.
§§Cough includes cough, productive cough, upper-airway cough syndrome.
||||Dyspnea includes dyspnea, dyspnea exertional.
¶¶Rash includes dermatitis, dermatitis acneiform, eczema, palmar-plantar, erythrodysaesthesia syndrome, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pustular.
##Only includes a Grade 3 adverse reaction.
Clinically relevant adverse reactions in <15% of patients who received GAVRETO included increased tumor lysis syndrome and creatine phosphokinase.
Laboratory Abnormality*** | GAVRETO (N=138) | |
Grades 1-4 (%) | Grades 3-4 (%) | |
Chemistry | ||
Decreased calcium (corrected) | 70 | 9 |
Increased aspartate aminotransferase (AST) | 69 | 4.3 |
Increased alanine aminotransferase (ALT) | 43 | 3.6 |
Increased creatinine | 41 | 0 |
Decreased albumin | 41 | 1.5 |
Decreased sodium | 28 | 2.2 |
Decreased phosphate | 28 | 8 |
Decreased magnesium | 27 | 0.7 |
Increased potassium | 26 | 1.4 |
Increased bilirubin | 24 | 1.4 |
Increased alkaline phosphatase | 22 | 1.4 |
Hematology | ||
Decreased lymphocytes | 67 | 27 |
Decreased hemoglobin | 63 | 13 |
Decreased neutrophils | 59 | 16 |
Decreased platelets | 31 | 2.9 |
***Denominator for each laboratory parameter is based on the number of patients with a baseline and post-treatment laboratory value available, which ranged from 135 to 138 patients.
Other clinically relevant laboratory abnormalities in patients who received GAVRETO included increased phosphate (40%).
Blueprint Medicines Corporation and Genentech, Inc. are not responsible for any information, statements, or other content you may encounter on third-party websites.
Blueprint Medicines Corporation and Genentech, Inc. are not responsible for any information, statements, or other content you may encounter on third-party websites.