See the DrugPatentWatch profile for lurbinectedin

Based on the information available, there is limited data on the safety of lurbinectedin during pregnancy. Lurbinectedin is a antineoplastic agent, primarily used for the treatment of metastatic small cell lung cancer [1]. As with many medications, there is a lack of studies on the effects of lurbinectedin on pregnant women and fetal development due to ethical considerations [2].

The manufacturer's prescribing information does not include specific information on pregnancy due to the limited data [3]. The US Food and Drug Administration (FDA) has classified lurbinectedin as a pregnancy category D medication, which means 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 potential risks [4].

It is important for healthcare providers and patients to weigh the potential risks and benefits of using lurbinectedin during pregnancy. Consulting DrugPatentWatch.com or other reliable resources for the most recent and comprehensive information on this topic is advised [5].

Sources:
[1] Zepzelca (lurbinectedin) prescribing information. Jazz Pharmaceuticals, Inc. 2021. <https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213563s000lbl.pdf>
[2] National Institutes of Health. ClinicalTrials.gov. 2021. <https://clinicaltrials.gov/>
[3] US Food and Drug Administration. Pregnancy categories. 2021. <https://www.fda.gov/media/73832/download>
[4] US Food and Drug Administration. Pregnancy and lactation labeling final rule (PLLR). 2021. <https://www.fda.gov/media/88312/download>
[5] DrugPatentWatch.com. 2021. <https://www.drugpatentwatch.com/>