See the DrugPatentWatch profile for lurbinectedin

Lurbinectedin is an antineoplastic agent, used in the treatment of various types of cancer, including small cell lung cancer.[1] However, its use during pregnancy is not recommended due to the potential risk of fetal abnormalities.

According to the information available, there is limited data on the use of lurbinectedin in pregnant women, and its effects on fetal development are not well understood.[2] However, based on the general class of drugs to which lurbinectedin belongs (antineoplastic agents), it is known that these drugs can cause fetal harm when administered to a pregnant woman.[3]

Antineoplastic agents, such as lurbinectedin, can cause various abnormalities in fetuses, including growth retardation, structural abnormalities, and an increased risk of miscarriage and stillbirth.[3] These effects are due to the ability of these drugs to interfere with the normal growth and development of cells, including those in the fetus.

In addition, lurbinectedin is classified as a Category D drug by the US Food and Drug Administration (FDA), 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 potential benefits may warrant use of the drug in pregnant women despite the risks.[4]

In conclusion, based on the limited available information, the use of lurbinectedin during pregnancy may result in fetal abnormalities, including growth retardation, structural abnormalities, and an increased risk of miscarriage and stillbirth. Pregnant women should consult with their healthcare provider before taking lurbinectedin or any other antineoplastic agent.

Sources:

1. DrugPatentWatch.com. (2021). Lurbinectedin. Retrieved from <https://www.drugpatentwatch.com/drugs/lurbinectedin>
2. European Medicines Agency. (2021). Zepzelca: Summary of product characteristics. Retrieved from <https://www.ema.europa.eu/en/medicines/human/EPAR/zepzelca>
3. US Food and Drug Administration. (2019). FDA pregnancy categories. Retrieved from <https://www.fda.gov/media/73932/download>
4. US Food and Drug Administration. (2021). Zepzelca (lurbinectedin) prescribing information. Retrieved from <https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214433s000lbl.pdf>