Myeloid/lymphoid neoplasms with eosinophilia and TK fusions

The EU has approved 2 indications of 1 drug in myeloid/lymphoid neoplasms with eosinophilia and TK fusions. Each needs a biomarker result: FIP1L1::PDGFRA (1) and PDGFR (1).

Line of therapy

Approved indications, Myeloid/lymphoid neoplasms with eosinophilia and TK fusions
DrugBiomarker requirementRegimenSettingConditions
FIP1L1::PDGFRA fusion1
Imatinib
Glivec
FIP1L1-PDGFRalpha rearrangement
Monotherapy
Any line
advanced
None
PDGFR fusion1
Imatinib
Glivec
Monotherapy
Any line
None

Biomarkers in myeloid/lymphoid neoplasms with eosinophilia and TK fusions

Label wording2

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Imatinib (Glivec)
    adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
  2. Imatinib (Glivec)
    adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.