A Real-World Disproportionality Analysis of FDA Adverse Event Reporting System Events for Tazemetostat

Area of Science:

• Pharmacovigilance
• Oncology Drug Safety

Background:

• Tazemetostat, an EZH2 inhibitor, is approved for specific sarcomas and lymphomas.
• Limited post-marketing safety data exists for tazemetostat despite its increasing clinical use.

Purpose of the Study:

• To evaluate the real-world safety profile of tazemetostat.
• To identify adverse events associated with tazemetostat using FAERS data.

Main Methods:

• Analysis of 1,179 adverse event reports from the FDA Adverse Event Reporting System (FAERS) between Q1 2020 and Q4 2024.
• Utilized four disproportionality methods for signal detection.
• Standardized adverse events using MedDRA and performed subgroup and time-to-onset analyses.

Main Results:

• Confirmed known toxicities including gastrointestinal and hematologic events (fatigue, nausea, decreased appetite, anemia).
• Identified novel safety signals: taste disorder and somnolence, not previously listed in FDA labeling.
• Most adverse events occurred within 60 days of treatment initiation.

Conclusions:

• Real-world data confirms known tazemetostat toxicities and reveals new adverse event signals.
• Highlights the need for ongoing pharmacovigilance to monitor emerging safety concerns.
• Findings can inform real-world monitoring strategies for tazemetostat therapy.