Does lurbinectedin cause birth defects?
Lurbinectedin (Zepzelca), an alkylating agent used for metastatic small cell lung cancer, is embryotoxic, fetotoxic, and teratogenic in animal studies. It crosses the placenta and causes fetal harm when administered to pregnant patients, leading to birth defects or fetal death.[1][2] Human data is limited due to exclusion of pregnant women from trials, but its genotoxic mechanism—binding DNA and inhibiting cell division—makes it likely to cause congenital malformations.[3]
What do animal studies show?
In rats and rabbits, lurbinectedin at doses below human equivalents caused reduced fetal weight, skeletal abnormalities, and increased resorptions. No formal fertility studies exist, but ovarian atrophy occurred in female rats.[1][2] These findings classify it as Pregnancy Category D (positive evidence of human fetal risk).[4]
Is it safe during pregnancy?
No. Avoid use in pregnancy; females of reproductive potential must use effective contraception during treatment and for 6 months after the last dose. Verify pregnancy status before starting. Males should use contraception during treatment and for 4 months post-dose.[1][2] Discontinue breastfeeding during treatment and for 2 weeks after.[1]
What if someone gets pregnant on lurbinectedin?
Report exposure to the Zepzelca Pregnancy Exposure Registry (1-888-274-2378) or FDA's MedWatch. Immediate medical consultation is needed; fetal monitoring or termination may be advised based on gestational age and risks.[1][2]
How does it compare to similar cancer drugs?
Like other alkylators (e.g., cyclophosphamide), lurbinectedin carries high teratogenic risk, with animal data showing defects in organogenesis. Unlike some targeted therapies, its non-selective DNA damage affects rapidly dividing fetal cells.[3][5]
Sources
[1]: Zepzelca Prescribing Information (FDA)
[2]: Drugs.com - Lurbinectedin Pregnancy
[3]: PubChem - Lurbinectedin Mechanism
[4]: RxList - Zepzelca
[5]: ASCO Guidelines on Chemotherapy in Pregnancy