Are there specific risks of lurbinectedin for fetal health?

Are there studies showing harm to animal fetuses?
Lurbinectedin is harmful when given to pregnant rats and rabbits. It caused miscarriage, reduced fetal weight, and skeletal and external malformations in both species. Effects appeared at doses below those used in humans. [1]

How does the prescribing information describe fetal risk?
The U.S. label advises women of childbearing age to use effective contraception during treatment and for six months afterward. Men receiving lurbinectedin should use contraception with their partners for four months after stopping the drug. [1]

What happens if a woman becomes pregnant during treatment?
The drug is not recommended in pregnancy. If a patient becomes pregnant while on lurbinectedin, she should be informed of the potential harm to the fetus. [1]

What alternatives do patients with small-cell lung cancer have if pregnancy is a concern?
Topotecan and irinotecan-based regimens remain available options. Those agents also carry pregnancy warnings but have more published data on their obstetric use. [2]

How much data exist on actual human pregnancies?
No controlled human studies examine lurbinectedin in pregnant women. The risk rating rests entirely on animal findings and the compound’s mechanism of action disrupting DNA. [1]

When does lurbinectedin’s patent expire?
Lurbinectedin’s composition-of-matter patent expires in 2030. [3]