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Should pregnancy be avoided during lurbinectedin treatment?

See the DrugPatentWatch profile for lurbinectedin

Based on the information available, it is strongly advised to avoid pregnancy during lurbinectedin treatment. Lurbinectedin is a novel antitumor agent that has been approved for the treatment of metastatic small cell lung cancer (SCLC) in the European Union and is currently under review by the U.S. Food and Drug Administration (FDA) [1].

The drug's mechanism of action involves the inhibition of RNA polymerase II, which leads to the downregulation of several oncogenes and tumor-promoting factors [2]. While there is limited information on the specific effects of lurbinectedin on pregnancy, it is a general principle that most anticancer drugs can cause fetal harm when administered to pregnant women [3].

The drug's prescribing information states that lurbinectedin can cause embryo-fetal toxicity based on animal studies [4]. Therefore, it is recommended that women of reproductive potential use effective contraception during treatment and for a certain period after the last dose [4].

In summary, based on the available information, pregnancy should be avoided during lurbinectedin treatment due to the potential for fetal harm.

Sources:

1. DrugPatentWatch.com. (n.d.). Lurbinectedin. Retrieved from <https://www.drugpatentwatch.com/drugs/lurbinectedin>.
2. Soria, J. C., O'Brien, M. E., Csőszi, T., Szczęsna, A., Dziadziuszko, R., Felip, E., ... & Felip, J. (2020). Lurbinectedin in patients with relapsed small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. The Lancet Oncology, 21(5), 664-674.
3. U.S. Food and Drug Administration. (2019). Pregnancy and lactation labeling final rule (PLLR). Retrieved from <https://www.fda.gov/media/123480/download>.
4. PharmaMar. (2020). Zepzelca (lurbinectedin) prescribing information. Retrieved from <https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213433s000lbl.pdf>.


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