(P-200) Safety Evaluation of Panobinostat, Ixazomib, Elotuzumab, and Daratumumab Using FDA Adverse Event Reporting System (FAERS) Database 2015 – 2020

Background: Multiple Myeloma (MM) is a type of blood cancer that affects plasma cells. Panobinostat, ixazomib, elotuzumab, and daratumumab are antineoplastic agents approved by the Food and Drug Administration (FDA) in 2015 to treat MM. Their adverse drug events and outcomes have not yet been explored in large populations.

Objectives: This study aimed to: 1) explore the frequency of adverse events and outcomes linked to the MM medications including panobinostat, ixazomib, elotuzumab, and daratumumab, and 2) summarize patient demographics associated with the adverse events related to MM medications.

Methods: A retrospective descriptive data analysis study to analyze all reported adverse events associated with panobinostat, ixazomib, elotuzumab, and daratumumab reported to the United States FDA Adverse Event Reporting System (FAERS). The study period was from the first quarter of 2015 until the second quarter of 2020. The total number and the most common adverse events were calculated annually for each medication. Also, demographic data including average age and gender were obtained and compared between the study medications. We also compared the adverse events' outcomes and categorized them into death, life-threatening, disability, hospitalization, and other outcomes. We used SAS software version 9.4 (Cary, NC, USA) along with Microsoft Excel (Microsoft Corporation, Redmond, WA, USA) to analyze the data.

Results: Ixazomib had the highest adverse events with 17,060 (49%) reports, followed by daratumumab with 12,380 (35%) reports, elotuzumab with 3,618 (10%) reports, and finally panobinostat with 1,846 (5%) reports. Males experienced more adverse events than females in all four MM medications (54% vs 46%). Mean ages (SD) of reported patients were 61 (± 9.8) for panobinostat, 67 (± 2.0) for elotuzumab, 69 (± 2.7) for daratumumab, and 70 (± 2.1) for ixazomib. While the most frequent adverse events varied between the four medications, pneumonia (9%) and diarrhea (9%), and thrombocytopenia (8%) were the most common reported adverse events that all the medications share. Ixazomib and daratumumab were the medications with the highest number of adverse events yielding hospitalizations (5998 vs 4977 cases) and deaths (2592 vs 1952 cases).

Conclusions: Comparing the adverse events of four new MM medications, ixazomib had the highest frequency of adverse events reported, followed by daratumumab, elotuzumab, and panobinostat, respectively.