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Relatlimab

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IDDRUG-RELATLIMAB
TipoFármaco
Alegais
BMS-986016Opdulag (combinação de dose fixa com nivolumab)relatlimab-rmbwРелатлімаб
Estadoreviewed 2026-04-27 | pending_clinical_signoff
DoençasDIS-MELANOMA
FontesSRC-ESMO-MELANOMA-2024 SRC-NCCN-MELANOMA-2025

Fatos sobre as drogas

ClasseAnticorpo monoclonal anti- LAG-3 (inibidor do ponto de controlo imune)
MecanismoFully human IgG4 monoclonal antibody binding lymphocyte-activation gene 3 (LAG-3, CD223), an inhibitory checkpoint receptor expressed on activated/exhausted T cells, regulatory T cells, and NK cells. By blocking LAG-3 / MHC class II and LAG-3 / FGL1 interactions, relatlimab restores effector T-cell function in the tumor microenvironment, particularly when combined with PD-1 blockade (which targets a non-redundant exhaustion pathway). First-in-class anti-LAG-3 approved for clinical use; available only as a fixed-dose combination with nivolumab (Opdualag). Pivotal evidence RELATIVITY-047 (1L unresectable / metastatic melanoma): nivolumab + relatlimab vs nivolumab monotherapy mPFS 10.2 vs 4.6 mo (HR 0.75); G3+ irAE rate ~21% vs ~12% (clearly lower than nivo+ipi ~55%).
Dose típicaFixed-dose combination Opdualag: relatlimab 160 mg + nivolumab 480 mg IV over 30 minutes every 4 weeks. Single-vial co-formulation — cannot be dosed independently. Continue until disease progression, unacceptable toxicity, or up to 24 months. No dose adjustment for renal or hepatic impairment (mAb catabolism). Hold for G2-3 irAE (both components held); permanently discontinue for G4 irAE, myocarditis, or recurrent G3 despite re-treatment.
Ucrânia registadaFalso
NSZU reembolsadoFalso
Ucrânia verificada pela última vez2026-04-27

Notas

Toxicity profile is favorable vs nivo+ipi doublet (G3+ irAE ~21% vs ~55%) with comparable PFS — positions Opdualag as a less-toxic ICI doublet for patients in whom CTLA-4 toxicity is a major concern (older, frail, prior autoimmune history with caution). Hepatitis rate may be modestly higher than nivo monotherapy alone. Baseline workup: TFTs, LFTs, creatinine, cortisol, HbA1c, lipase, troponin if cardiac risk, HBV/HCV serology, dermatologic + pulmonary review, baseline imaging. Monitor TFTs / LFTs / creatinine before each dose for first 6 cycles. Hospitalize and start IV methylprednisolone 1-2 mg/kg/day for G3-4 irAE; consult organ-specialist; escalate to infliximab / mycophenolate / IVIG / ATG for steroid-refractory cases (per ASCO / NCCN / ESMO irAE-management guidelines). Cannot be dose-fractionated — both agents are co-formulated in a single vial.

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