ATC codes:
L01FF02
Indication
Melanoma of skin
ICD11 code:
2C30
INN
Pembrolizumab
Medicine type
Biological agent
List type
Core
Additional notes
*including quality-assured biosimilars
Formulations
Parenteral > General injections > IV:
25 mg per mL in 4 mL vial
EML status history
First added in 2025
(TRS
1064)
Sex
All
Age
Adolescents and adults
Therapeutic alternatives
Patent information
Main patent is active in several jurisdictions. For more information on specific patents and
license status for developing countries visit www.MedsPal.org
Read more
about patents.
Summary of evidence and Expert Committee recommendations
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.