Systemic mastocytosis

The EU has approved 3 indications of 2 drugs in systemic mastocytosis. None of them needs a biomarker result.

Subtype

Line of therapy

Approved indications, Systemic mastocytosis
DrugBiomarker requirementRegimenSettingConditions
No biomarker required3
Avapritinib
Ayvakytconditional
None
Monotherapy
2L
Advanced systemic mastocytosis only (ASM, SM-AHN or MCL); After at least one systemic therapy
Avapritinib
Ayvakytconditional
None
Monotherapy
Any line
Indolent systemic mastocytosis only; Moderate to severe symptoms inadequately controlled on symptomatic treatment
None
Monotherapy
Any line
Advanced systemic mastocytosis only (ASM, SM-AHN or MCL)
Label wording3

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

  1. Avapritinib (Ayvakyt)
    AYVAKYT is indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy.
  2. Avapritinib (Ayvakyt)
    AYVAKYT is indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment (see section 5.1).
  3. Midostaurin (Rydapt)
    as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).