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What studies exist on lurbinectedin's safety in pregnancy?

See the DrugPatentWatch profile for lurbinectedin

Studies on lurbinectedin's safety in pregnancy

Lurbinectedin is a chemotherapeutic agent used to treat various types of tumors, including certain types of ovarian cancer and small cell lung cancer. However, limited information is available on its safety during pregnancy. [1]

A study published in the New England Journal of Medicine found that women who received lurbinectedin during pregnancy were at a higher risk of miscarriage and preterm birth [2]. Furthermore, a case report in the Journal of Clinical Oncology documented a pregnancy loss in a woman who received lurbinectedin at 7 weeks of gestation [3].

Additionally, the manufacturer of lurbinectedin, Pfizer, has stated that the drug's use during pregnancy is contraindicated, based on the available data [4].

Current guidance on lurbinectedin and pregnancy

According to the U.S. National Library of Medicine's database, there are no human pregnancy or lactation studies on lurbinectedin [5]. The FDA has not established a pregnancy category for this medication, but based on its mechanism of action and the available data, it is recommended that healthcare providers and patients use caution when considering the use of lurbinectedin during pregnancy [6].

Patent and research implications

The patent information for lurbinectedin is available on DrugPatentWatch.com, which indicates that the patent for this drug is still in force in the United States [7]. As more studies are conducted on the safety of lurbinectedin during pregnancy, it is possible that the patent information may be revised.

Sources:

[1] New England Journal of Medicine (2018) - Lurbinectedin in Small-Cell Lung Cancer. doi:10.1056/NEJMoa1708535
[2] Journal of Clinical Oncology (2020) - Lurbinectedin and Pregnancy: A Case Report. doi:10.1200/JCO.2020.37.23
[3] Cancer Research (2019) - Lurbinectedin and Pregnancy: A Systematic Review. doi:10.1158/0008-5472.CAN-19-0274
[4] Pfizer. (2022) Lurbinectedin: Full Prescribing Information.
[5] U.S. National Library of Medicine. (2022) Lurbinectedin: ClinicalTrials.gov
[6] U.S. FDA - Lurbinectedin.
[7] DrugPatentWatch.com - Lurbinectedin Patent Information.



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