Lurbinectedin is a drug used for the treatment of certain types of cancer. The drug has been approved by the FDA for the treatment of metastatic small cell lung cancer (SCLC) in patients who have progressed after previous treatment. [3]

According to the FDA, there are ongoing safety monitoring efforts for lurbinectedin. The FDA requires the manufacturer to conduct post-marketing studies to evaluate the long-term safety of the drug. The manufacturer is also required to report any adverse events associated with the use of the drug to the FDA. [3]

The safety and efficacy of lurbinectedin were evaluated in clinical trials involving patients with SCLC. The trials showed that the drug was effective in treating the disease, and the side effects were generally manageable. The most common side effects observed in the trials were fatigue, nausea, decreased appetite, musculoskeletal pain, and vomiting. [2]

However, it is important to note that like all drugs, lurbinectedin may cause serious side effects. These include myelosuppression, which can lead to infections, bleeding, and anemia, and hepatotoxicity, which can lead to liver failure. Patients taking lurbinectedin should be monitored for these and other potential side effects. [3]

In conclusion, there are ongoing safety monitoring efforts for lurbinectedin, and the drug has been approved by the FDA for the treatment of metastatic SCLC. Patients taking lurbinectedin should be monitored for potential side effects, and the manufacturer is required to report any adverse events to the FDA. [2][3]

Sources:
[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6331752/
[3] https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213702s000lbl.pdf