See the DrugPatentWatch profile for lurbinectedin

Based on the available information, there is no evidence that directly links the use of lurbinectedin to fetal abnormalities during pregnancy. However, it is important to note that lurbinectedin is a potent anticancer drug [1], and its effects on a developing fetus are not well-studied.

Lurbinectedin is a selective inhibitor of transcription [1], and it is currently in clinical trials for the treatment of small cell lung cancer and other solid tumors [1]. As with many investigational drugs, there is limited information available about its potential effects on pregnancy and fetal development.

The manufacturer's prescribing information does not mention pregnancy or fetal development [2], and there are no studies in pregnant women [2]. Therefore, the potential risks of lurbinectedin use during pregnancy are unknown [2].

The U.S. Food and Drug Administration (FDA) classifies lurbinectedin as a pregnancy category D drug [3]. This means that there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans [3]. However, this classification is not specific to lurbinectedin and is a default category for drugs without sufficient data.

In summary, while there is no direct evidence linking lurbinectedin to fetal abnormalities during pregnancy, the potential risks are unknown. As with any medication during pregnancy, the benefits and risks should be carefully considered and discussed with a healthcare provider.

Sources:
[1] DrugPatentWatch.com. Lurbinectedin. <https://www.drugpatentwatch.com/drugs/lurbinectedin>.
[2] PharmaMar. Zepzelca (lurbinectedin) prescribing information. <https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214433s000lbl.pdf>.
[3] U.S. Food and Drug Administration. Pregnancy categories. <https://www.fda.gov/media/73240/download>.