Codes ATC:
L01FF02
Indication
Melanoma of skin
Code ICD11:
2C30
INN
Pembrolizumab
Type de médicament
Biological agent
Type de liste
Liste de base
Additional notes
*including quality-assured biosimilars
Formulations
Parenteral > General injections > IV:
25 mg per mL in 4 mL vial
Historique des statuts LME
Ajouté pour la première fois en 2025
(TRS
1064)
Sexe
Tous
Âge
Adolescents et adultes
Équivalence thérapeutique
Renseignements sur le brevet
Main patent is active in several jurisdictions. For more information on specific patents and
license status for developing countries visit www.MedsPal.org
Lire la suite
sur les brevets.
Résumé des preuves et recommandation du comité d'experts
With the 2025 recommendation to list pembrolizumab for first-line monotherapy of metastatic non-small cell lung cancer with high PD-L1 expression (≥ 50%), first-line monotherapy for deficient mismatch repair/microsatellite instability-high metastatic colorectal cancer, and in combination with platinum-based chemotherapy, as first-line treatment of metastatic cervical cancer with PD-L1 expression ≥ 1%, the Expert Committee recommended changing the current square box listing of nivolumab as the class representative and pembrolizumab as the specified therapeutic alternative for metastatic melanoma, to make pembrolizumab the class representative with nivolumab as the specified therapeutic alternative. This is intended to signal to countries the possibility of aggregating procurement of a single molecule, pembrolizumab, for multiple cancer indications, which can influence price negotiations with manufacturers. Limiting procurement fragmentation by focusing on a select few immune checkpoint inhibitors is likely to facilitate central purchasing through competitive tendering and better competition from pembrolizumab biosimilars, thereby increasing access.