Retevmo safety and tolerability were evaluated in 796 patients1
- Dose interruptions and dose reductions due to ARs occurred in 64% and 41% of patients who received Retevmo, respectively.1 See full Prescribing Information for dose modifications.
- ARs requiring dosage interruption in ≥5% of patients included increased ALT, increased AST, diarrhea, and hypertension.1
- ARs requiring dosage reductions in ≥2% of patients included increased ALT, increased AST, QT prolongation, fatigue, diarrhea, drug hypersensitivity, and edema.1
- Clinically relevant ARs in ≤15% of patients who received Retevmo include hypothyroidism (13%), hypersensitivity (6%), interstitial lung disease/pneumonitis, chylothorax, chylous ascites, or tumor lysis syndrome (all <2%).1
8% (n=64) of patients permanently discontinued Retevmo (N=796) due to adverse reactions. 3% (n=25) were considered treatment-related, as assessed by trial investigator. Adverse reactions resulting in permanent discontinuation in ≥0.5% of patients included increased ALT (0.6%), fatigue (0.6%), sepsis (0.5%), and increased AST (0.5%).1,3
Due to rounding and potential double-counting of patients, percentages presented may not add up to the indicated totals.
*Diarrhea, abdominal pain, fatigue, edema, rash, headache, cough, dyspnea, and hemorrhage are consolidated terms. See full Prescribing Information for list of consolidated terms.1
†Denominator for each laboratory parameter is based on the number of patients with a baseline and post-treatment laboratory value available, which ranged from 765 to 791 patients.1
Retevmo is a kinase inhibitor indicated for the treatment of:
- adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test
- adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy*
- adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)*
- adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options*
*These indications are approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.