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Velcade (Bortezomib) & Nervous System Disorders

Basic Details
Status
Complete
Last Updated
Wednesday, July 2, 2025
Original Posting Date
Health Outcome(s)
nervous system disorders
Purpose
Methods, Characterization, or Development
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

Velcade (bortezomib) was approved by the U.S. Food and Drug Administration (FDA) in June 2008 for the treatment of multiple myeloma, a cancer of plasma cells. FDA initiated this study in the Sentinel System to explore the feasibility of assessing the rates and timing of the development of health outcomes after initiating bortezomib therapy, focusing on amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, Parkinson’s disease, frontotemporal lobar degeneration (FTLD), amyloidosis, and dementia.

Findings showed that few events were observed among new bortezomib users (N=24,832). ALS had the least (4 events among new users; 2.76 events per 10,000 years at risk); dementia had the most (471 events among new users; 328.75 events per 10,000 years at risk).

The results from this exploratory study informed FDA about the feasibility of identifying the events of interest in the Sentinel Distributed Database.
 

Result(s) (2)
Rates of Nervous System Disorders Following Bortezomib Use in Patients: A Descriptive Analysis Prevalent and Incident Use of Bortezomib: A Descriptive Analysis