Are there any known birth defects associated with lurbinectedin?

What birth defects have been reported with lurbinectedin?

Lurbinectedin has not been shown to cause specific structural birth defects in humans. Animal studies indicate it may affect development, but clinical data in pregnant women remain very limited.

What animal studies show

In rabbits and rats, lurbinectedin caused embryo-fetal toxicity and malformations when given at doses higher than the human dose. These observations led the FDA to assign Pregnancy Category D.

Pregnancy Category D means the risk to the women who use the drug during pregnancy cannot be ruled out.

Can women of childbearing age use lurbinectedin?

Women who could become pregnant must use effective contraception during treatment and for at least four months after the last dose. Men who are sexually active with women of childbearing potential must use contraception for at least four months as well.

How does lurbinectedin affect pregnancy outcomes?

No clinical trials enrolled pregnant women. No cases of birth defects were reported in spontaneous adverse-event reports.