What studies link lurbinectedin to fetal abnormalities?

What studies link lurbinectedin to fetal abnormalities?

Lurbinectedin has not been studied in pregnant women. Animal studies show it can cause fetal abnormalities when given to rats and rabbits during pregnancy.

What did the animal studies find?

In rats, maternal doses of 0.09 mg/kg/day and higher produced external, soft tissue, and skeletal malformations in fetuses. At 0.009 mg/kg/day, lurbinectedin was still able to produce fetal body weight reductions and delayed ossification. The lowest dose tested in rats was 0.009 mg/kg/day, which equals roughly 0.1 times the human recommended dose.

In rabbits, maternal doses of 0.008 mg/kg/day and higher produced fetal skeletal variations and delayed ossification. At 0.002 mg/kg/day, lurbinectedin produced fetal body weight reductions. The lowest dose tested in rabbits was 0.002 mg/kg/day, which equals roughly 0.03 times the human recommended dose.

How does lurbinectedin work?

Lurbinectedin works by binding DNA minor groove and interfering with transcription. It can produce severe damage to DNA in rapidly dividing cells, which explains its effect on fetal development.

What happens if a woman gets treated during pregnancy?

No clinical trials or real-world reports document fetal abnormalities in humans. All current recommendations advise women to use effective contraception during treatment and for three months after stopping lurbinectedin. Men whose partners are pregnant or planning to conceive should use condoms during treatment and for four months after stopping the drug.

How is lurbinectedin regulated around pregnancy?

Lurbinectedin is labeled Pregnancy Category D in the US. It is recommended that a pregnancy test be performed before starting the drug.