Are there any reported cases of birth defects with lurbinectedin?

What reports exist of birth defects linked to lurbinectedin?
No published cases of birth defects have been identified in clinical trial data or post-marketing surveillance for lurbinectedin. The drug carries an FDA pregnancy category warning because its mechanism of action—DNA damage—raises theoretical risk to a developing fetus.

How does the pregnancy warning on lurbinectedin compare with other oncology agents?
Most cytotoxic chemotherapies carry similar warnings; however, lurbinectedin’s label emphasizes both embryo-fetal toxicity and the need for effective contraception during treatment and for at least six months afterward for women of childbearing potential.

Why does the FDA require contraception for six months after lurbinectedin?
The six-month interval reflects the drug’s long half-life and the time needed for clearance of potential genotoxic effects on oocytes.

Can lurbinectedin be used safely in pregnancy if benefits outweigh risks?
Current guidance advises against use in pregnancy unless no alternative exists. If exposure occurs, patients are advised to enroll in a pregnancy registry to track outcomes.

What data sources track lurbinectedin pregnancy outcomes?
The manufacturer maintains a pregnancy exposure registry, and the FDA’s Adverse Event Reporting System (FAERS) continues to monitor reports. As of the latest update, no congenital anomalies have been submitted to these databases.