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L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

This group comprises preparations used in the treatment of neoplastic diseases, and immunomodulating agents.
Corticosteroids for systemic use, see H02.


L01 ANTINEOPLASTIC AGENTS

Combination products are classified in L01XY - Combinations of antineoplastic agents, except for combinations of monoclonal antibodies or antibody drug conjugates which are classified in L01FY.
Detoxifying agents used in connection with high dose treatment of antineoplastic agents are classified in V03AF (e.g. calcium folinate).
Radiopharmaceuticals used in the treatment of cancer are classified in V10X.

DDDs have been established for the protein kinase inhibitors in L01E only.
No DDDs have been established for substances classified in ATC 3rd level L01A, L01B, L01C, L01D, L01F or L01X. This is because of highly individualised use and wide dosage ranges. The doses used vary substantially because of various types and severity of neoplastic diseases, and also because of the extensive use of combination therapy.
The consumption of antineoplastic agents is in some countries measured in grams. This is recommended as a method to be used internationally for these particular agents.


L01E PROTEIN KINASE INHIBITORS

This group comprises protein kinase inhibitors used for neoplastic diseases. Substances are classified according to their main target.

Substances which are multi-targeted without a clear main target are classified in L01EX.
Lipid kinase inhibitors (phosphatidylinositol-3-kinase (Pi3K) inhibitors) are classified in L01EM.


L01EA BCR-ABL tyrosine kinase inhibitors

The DDDs are based on the standard starting dose in the treatment of chronic myeloid leukemia in early phase (chronic phase).

L01EB Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors

Substances inhibiting both HER2 and EGFR indicated for breast cancer are classified in L01EH.

The DDD for erlotinib is based on the treatment of non-small cell lung cancer (NSCLC).

L01EC B-Raf serine-threonine kinase (BRAF) inhibitors

The DDD for encorafenib is based on the treatment of melanoma.

L01ED Anaplastic lymphoma kinase (ALK) inhibitors

Substances which are multi-targeted, but where ALK is considered the main target, are classified in this group.

L01EE Mitogen-activated protein kinase (MEK) inhibitors
L01EF Cyclin-dependent kinase (CDK) inhibitors
L01EG Mammalian target of rapamycin (mTOR) kinase inhibitors

Parenteral and topical dermatological formulations of sirolimus for neoplastic diseases are classified in this group. Oral formulations of sirolimus used for organ transplantation are classified in L04AH.

L01EH Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors

Substances inhibiting both HER2 and EGFR indicated for breast cancer are classified in this group.

L01EJ Janus-associated kinase (JAK) inhibitors

The DDDs are based on the treatment of myelofibrosis.

L01EK Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
L01EL Bruton's tyrosine kinase (BTK) inhibitors

The DDD for ibrutinib is based on the treatment of chronic lymphocytic leukaemia (CLL) .

L01EM Phosphatidylinositol-3-kinase (Pi3K) inhibitors
L01EN Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
L01EX Other protein kinase inhibitors

This group comprises other protein kinase inhibitors which cannot be classified in the preceding groups. Substances which are multi-targeted without a clear main target are also classified in this group.

The DDD for cabozantinib is based on the treatment (tablets) of renal cell carcinoma and hepatocellular carcinoma.
The DDD for lenvatinib is based on the treatment of renal cell carcinoma.
The DDD for midostaurin is based on the treatment of acute myeloid leukaemia (AML).

Last updated: 2024-01-26