INDICATIONS
Retevmo is a kinase inhibitor indicated for the treatment of :
• adult patients with metastatic RET fusion-positive non-small cell lung cancer ( NSCLC )
• adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer ( MTC ) who require systemic therapy
• adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory ( if radioactive iodine is appropriate )
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 .
RET = rearranged during transfection .
IMPORTANT SAFETY INFORMATION
Hepatotoxicity : Serious hepatic adverse reactions occurred in 2.6 % of patients treated with Retevmo . Increased aspartate aminotransferase ( AST ) occurred in 51 % of patients , including Grade 3 or 4 events in 8 % and increased alanine aminotransferase ( ALT ) occurred in 45 % of patients , including Grade 3 or 4 events in 9 %. The median time to first onset for increased AST was 4.1 weeks ( range : 5 days to 2 years ) and increased ALT was 4.1 weeks ( range : 6 days to 1.5 years ). Monitor ALT and AST prior to initiating Retevmo , every 2 weeks during the first 3 months , then monthly thereafter and as clinically indicated . Withhold , reduce dose or permanently discontinue Retevmo based on the severity .
Hypertension occurred in 35 % of patients , including Grade 3 hypertension in 17 % and Grade 4 in one ( 0.1 %) patient . Overall , 4.6 % had their dose interrupted and 1.3 % had their dose reduced for hypertension . Treatment-emergent hypertension was most commonly managed with anti-hypertension medications . Do not initiate Retevmo in patients with uncontrolled hypertension . Optimize blood pressure prior to initiating Retevmo . Monitor blood pressure after 1 week , at least monthly thereafter , and as clinically indicated . Initiate or adjust anti-hypertensive therapy as appropriate . Withhold , reduce dose , or permanently discontinue Retevmo based on the severity .
Please see Important Safety Information and Brief Summary of Prescribing Information for Retevmo on subsequent pages .