Post-marketing safety assessment of mirvetuximab soravtansine: a disproportionality analysis based on the FDA Adverse Event Reporting System.

OBJECTIVE

Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate that targets the folate receptor-alpha and is used for the treatment of platinum-resistant ovarian cancer, though post-marketing safety data remain limited. This study aimed to perform a post-marketing safety assessment of MIRV based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

METHODS

Adverse event (AE) reports of MIRV as the primary suspected drug were collected from the FAERS database (Q4 2022 to Q4 2025). Four main methods of disproportionality analysis, including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma poisson shrinker, were employed for signal detection. Additionally, clinical priority and time-to-onset characteristics were assessed.

RESULTS

Two thousand five hundred eighty-two AEs associated with MIRV were identified in 1,252 unique patients. The system organ classes of eye and gastrointestinal disorders were the most frequently affected by MIRV. Thirty-nine preferred terms (PTs) were detected as positive safety signals. The most frequently reported AEs were vision blurred, neuropathy peripheral, cataract, diarrhea, abdominal pain and pneumonitis. Several unexpected safety signals, including blindness, colitis, pulmonary fibrosis, glaucoma, intestinal perforation, and ulcerative keratitis, were also identified. None of the positive PTs were classified as strong clinical priority. Furthermore, exploratory findings suggest the peak onset period for MIRV-associated AEs appears to be the first month of treatment.

CONCLUSION

This study confirms the known safety profile of MIRV and identifies several unexpected safety signals. However, as these unexpected safety signals are only hypothesis-generating, prospective studies are still required to confirm causality.