Post-Market Safety Analysis of Mirvetuximab Soravtansine: A Pharmacovigilance Analysis from a Large, Real-World Database.

BACKGROUND: Mirvetuximab soravtansine (MIRV) received FDA approval for FRα-positive, platinum-resistant epithelial ovarian cancer. Its post-marketing safety profile outside the trial setting has not been systematically characterized. METHODS: A retrospective disproportionality analysis was conducted using the FDA Adverse Event Reporting System (FAERS). Frequentist metrics and Bayesian metrics were calculated for all MIRV-event pairs. RESULTS: Of 474 drug-event pairs evaluated, 56 (11.8%) met signal criteria. Ocular toxicity dominated, with 22 signals including keratopathy (PRR = 1306.90; n = 35) and corneal epithelial microcysts (PRR = 2318.20; n = 5). Pneumonitis was the most clinically prominent non-ocular signal (PRR = 61.63; n = 57). Peripheral neuropathy had the highest absolute case count (n = 65; PRR = 19.41). CONCLUSIONS: Post-marketing FAERS data corroborate the established safety profile, with strong disproportionality signals for ocular toxicity, pneumonitis, and peripheral neuropathy. These findings and underscore the need for prospective confirmation as MIRV exposure accumulates.