See the DrugPatentWatch profile for lurbinectedin
Lurbinectedin is an antineoplastic agent, used for the treatment of metastatic small cell lung cancer. According to the information available, there are no specific fetal abnormalities directly linked to lurbinectedin. However, it is classified as a pregnancy category D drug by the 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 [1].
Lurbinectedin can cause fetal harm when administered to a pregnant woman. It may cause harm to the fetus when administered to a pregnant woman or can affect reproductive capacity. Animal studies have shown reproductive toxicity [2]. Therefore, lurbinectedin should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.
It is important to note that the use of lurbinectedin during pregnancy is not recommended, and effective contraception should be used during treatment and for a period of time after completing treatment [2].
In summary, while there are no specific fetal abnormalities directly linked to lurbinectedin, it is a pregnancy category D drug, and its use during pregnancy is not recommended due to the potential risk of fetal harm.
Sources:
[1] FDA. (2015). Pregnancy and Lactation Labeling Rule (PLLR). <
https://www.fda.gov/media/89035/download>
[2] DrugPatentWatch. (2021). Lurbinectedin. <
https://www.drugpatentwatch.com/drugs/lurbinectedin>