Three years of AYVAKIT® (avapritinib) efficacy and safety data

AYVAKIT was generally well tolerated in PIONEER2

ADVERSE REACTIONS OCCURRING IN PATIENTS WITH ISM DURING THE PIONEER TRIAL2

  • Serious adverse reactions occurred in 1 patient (0.7%) who received AYVAKIT due to pelvic hematoma
  • Permanent discontinuation of AYVAKIT due to an adverse reaction occurred in 1 patient (0.7%) due to dyspnea and dizziness
  • Dosage interruptions of AYVAKIT due to an adverse reaction occurred in 5% of patients
AYVAKIT® (avapritinib) adverse reactions occurring in patients with ISM during the PIONEER clinical trial

a Adverse reactions that occurred in ≥5% of AYVAKIT-treated patients and ≥2% more than placebo-treated patients.

b Per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

c Eye edema includes periorbital edema, eye edema, swelling of eyelid, orbital edema, eye swelling, eyelid edema, and eyelid ptosis.

d Term includes several similar terms.

e Respiratory tract infection includes pneumonia, upper respiratory tract infection, bronchitis, and respiratory tract infection.

f Hematoma includes contusion, hematoma, and pelvic hematoma.

g Hemorrhage includes epistaxis, gingival bleeding, hematochezia, rectal hemorrhage, and retinal hemorrhage.

BSC=best supportive care; ISM=indolent systemic mastocytosis.

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DOSING
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References: 1. Data on file. Blueprint Medicines Corporation, Cambridge, MA. 2. AYVAKIT [prescribing information]. Cambridge, MA: Blueprint Medicines Corporation; November 2024.