Ayvakit FDA Approval History
Last updated by Judith Stewart, BPharm on May 30, 2023.
FDA Approved: Yes (First approved January 9, 2020)
Brand name: Ayvakit
Generic name: avapritinib
Dosage form: Tablets
Company: Blueprint Medicines Corporation
Treatment for: Gastrointestinal Stromal Tumor, Systemic Mastocytosis
Ayvakit (avapritinib) is a tyrosine kinase inhibitor for use in the treatment of gastrointestinal stromal tumors, advanced systemic mastocytosis, and indolent systemic mastocytosis.
- Ayvakit is indicated for:
- Gastrointestinal Stromal Tumor (GIST) - treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.
- Advanced Systemic Mastocytosis (AdvSM) - treatment of adult patients with AdvSM. AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).
- Indolent Systemic Mastocytosis (ISM) - treatment of adult patients with ISM.
- GIST is a sarcoma of the GI tract most often caused by mutations in KIT or PDGFRA that force protein kinases into an increasingly active state. Systemic mastocytosis (SM) is a rare hematologic disorder most often caused by the KIT D816V mutation. Ayvakit works in the treatment of GIST and SM by targeting KIT D816V, PDGFRA and PDGFRA D842 mutants.
- Ayvakit is administered orally, once daily.
- Warnings and precautions associated with Ayvakit include intracranial hemorrhage, cognitive adverse reactions, photosensitivity reactions, and fetal harm.
- Common adverse reactions in patients with GIST include edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, increased lacrimation, abdominal pain, constipation, rash, dizziness, and hair color changes.
Common adverse reactions in patients with AdvSM include edema, diarrhea, nausea, and fatigue/asthenia.
Common adverse reactions in patients with ISM include eye edema, dizziness, peripheral edema and flushing.
Development timeline for Ayvakit
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