What changed: Systemic mastocytosis
Every dated change on the records linked to Systemic mastocytosis, newest first: approvals and regulatory steps on its medicines, trials that reported, guideline versions, milestones, and when this page itself was checked. Dates come from the records; none is inferred. Orientation, not medical advice.
September 2026 · 1
2023 · 2
- 2023GuidelineSystemic mastocytosisGuideline NCCN Guidelines: Systemic Mastocytosis; PIONEER (NEJM Evidence 2023): Indolent SM, symptomatic
H1 and H2 antihistamines, cromolyn, leukotriene antagonists, omalizumab for anaphylaxis, epinephrine autoinjector, bone protection; avapritinib 25 mg daily for moderate to severe symptoms uncontrolled by these (PIONEER). (NCCN Category 2A)
- 2023MilestoneAvapritinibAvapritinib approved for indolent SM
PIONEER; FDA approval May 2023, the first therapy for the indolent form.
2021 · 3
- 2021ApprovalAvapritinibAvapritinib approved in US
Advanced systemic mastocytosis
- 2021GuidelineSystemic mastocytosisGuideline NCCN Guidelines: Systemic Mastocytosis; PATHFINDER (Nature Medicine 2021): Advanced SM, first line
Avapritinib 200 mg daily (platelets above 50 x 10^9/L) as preferred agent; midostaurin as alternative or where platelets are low. (NCCN Category 2A (preferred: avapritinib))
- 2021MilestoneAvapritinibAvapritinib approved for advanced SM
EXPLORER and PATHFINDER; FDA approval June 2021.