Lurbinectedin is a medication used to treat patients with small cell lung cancer (SCLC) who have failed to respond to other treatments. According to the FDA, Lurbinectedin can cause fetal harm when administered to a pregnant woman. It is classified as a Pregnancy Category D drug, which means that there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks [2].

Animal studies have shown that Lurbinectedin can cause fetal harm when administered to pregnant animals. In a study conducted on rats, Lurbinectedin caused embryotoxicity and fetotoxicity at doses lower than the recommended human dose [2].

Therefore, it is recommended that women of reproductive age who are taking Lurbinectedin use effective contraception to prevent pregnancy during treatment and for at least 6 months after the last dose of Lurbinectedin. If a patient becomes pregnant while taking Lurbinectedin, they should be advised of the potential risks to the fetus and the need for close monitoring of fetal development [2].

In conclusion, Lurbinectedin has been shown to cause fetal harm when administered to pregnant animals, and is classified as a Pregnancy Category D drug. Women of reproductive age who are taking Lurbinectedin should use effective contraception to prevent pregnancy during treatment and for at least 6 months after the last dose of Lurbinectedin. If a patient becomes pregnant while taking Lurbinectedin, they should be advised of the potential risks to the fetus and the need for close monitoring of fetal development [2].

Sources:
[1] https://www.drugpatentwatch.com/p/tradename/LURBINECTEDIN
[2] https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213702s000lbl.pdf
[3] https://www.zepzelca.com/