Expert Opin Drug Saf
December 2024
Background: Ramucirumab (IMC-1121B) is a fully human immunoglobulin G1 monoclonal antibody, approved by the US Food and Drug Administration (FDA) for treating various cancers, including gastric, colorectal, liver, and non-small cell lung cancer. This study aimed to investigate the adverse events (AEs) associated with ramucirumab by utilizing data mining techniques on the FDA Adverse Event Reporting System (FAERS).
Methods: We collected ramucirumab-related data from the FAERS database, spanning from January 2014 to June 2023.
In this study, we delved into the safety profile of alpelisib, an FDA-approved treatment for hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, and PIK3CA-Related Overgrowth Spectrum (PROS). Despite its approval, real-world, long-term safety data is lacking. Our research scrutinizes the FDA database to assess alpelisib 's safety.
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