Cancers
Infectious Complications and Toxicities of the Teclistamab Plus Daratumumab Combination in Relapsed or Refractory Multiple Myeloma: A Disproportionality and Drug–Interaction Analysis of the FDA Adverse Event Reporting System
By Carmel Awadallah, Sohaib Irfan, Al-Ola A. Abdallah and 1 others.
Abstract
Background
Teclistamab plus daratumumab (Tec-Dara) was approved in March 2026 for relapsed or refractory multiple myeloma, but infections are frequent. We hypothesized that dual BCMA- and CD38-directed immune depletion causes infectious toxicity exceeding that expected from either agent alone.
Methods
In the FDA Adverse Event Reporting System (FAERS; Q4 2022–Q4 2025; all combination reports pre-approval), we compared reports listing both agents (n = 353) with teclistamab-only (n = 2774) and daratumumab-only (n = 19,230) reports. Interaction was quantified as Ω = RORcombination/(RORteclistamab × RORdaratumumab), where ROR is the reporting odds ratio, with sensitivity analyses addressing calendar period, sparse counts, comparator, and confounding.