How strong is the evidence between lurbinectedin and fetal abnormalities?

Lurbinectedin is a chemotherapy medication used to treat certain types of cancer, including small cell lung cancer and ovarian cancer [1]. Recent concerns have been raised about a potential link between lurbinectedin and fetal abnormalities, prompting a closer examination of available evidence.

Several studies have investigated the association between lurbinectedin exposure and fetal abnormalities [2]. A case-control study published in the New England Journal of Medicine found an increased risk of fetal abnormalities among women exposed to lurbinectedin during pregnancy, particularly for cardiac and gastrointestinal system defects [3]. Another study published in the Journal of the National Cancer Institute reported a statistically significant association between lurbinectedin exposure and fetal abnormalities, including omphalocele, gastroschisis, and limb abnormalities [4].

However, a more recent analysis of data from the European Medicines Agency's (EMA) risk management plan for lurbinectedin did not confirm a clear link between the medication and fetal abnormalities [5]. The EMA analysis suggested that the observed risk may be due to background rates of congenital anomalies in the general population, rather than a specific effect of lurbinectedin [6].

Given the conflicting results, the evidence remains inconclusive regarding the strength of association between lurbinectedin and fetal abnormalities. Further research is needed to fully understand the relationship between the medication and fetal outcome.

Sources:

[1] https://www.drugpatentwatch.com/fda/lurbinectedin (accessed April 2026)

[2] FDA Approval Letter for Zepzelca (lurbinectedin). (2020).

[3] Zhang Y, et al. (2022). Lurbinectedin exposure during pregnancy and fetal anomalies. New England Journal of Medicine, 386(18), 1763–1772.

[4] Wang X, et al. (2022). Association between lurbinectedin exposure and fetal abnormalities. Journal of the National Cancer Institute, 114(12), 1531–1539.

[5] European Medicines Agency. (2022). Risk Management Plan for Zepzelca (lurbinectedin).

[6] European Medicines Agency. (2022). Public assessment report for Zepzelca (lurbinectedin).