Nivolumab and Relatlimab (Opdualag)

Abstract

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec. This review assesses Nivolumab-relatlimab (Opdualag): nivolumab 12 mg/mL and relatlimab 4 mg/mL in a single-dose vial (fixed-dose combination), administered as an IV infusion over 30 minutes The recommended dosage in adult patients is 480 mg nivolumab and 160 mg relatlimab, every 4 weeks The recommended dosage for pediatric patients who are aged at least 12 years and weigh at least 40 kg is the same as for adults A recommended dosage has not been established for pediatric patients who are aged 12 years or older and weigh less than 40 kg Nivolumab-relatlimab is supplied as a concentrate for solution for infusion: 240 mg of nivolumab per 20 mL (12 mg/mL) and 80 mg of relatlimab per 20 mL (4 mg/mL) in a single-dose vial (fixed-dose combination). Indication: For the treatment of adult and pediatric patients aged 12 years or older with unresectable or metastatic melanoma who have not received prior systemic therapy for unresectable or metastatic melanoma.