Lurbinectedin is a new drug that has been approved by the FDA for the treatment of metastatic small cell lung cancer (SCLC) [3]. According to the FDA, lurbinectedin is only available through a restricted program called the ZEPHYRUS program [3]. This program is designed to ensure that the drug is used safely and effectively, and only by patients who are eligible to receive it [3].

The drug is not yet available in all countries, but it has been approved in the European Union under the brand name Zepsyre [2]. According to Drug Patent Watch, lurbinectedin is currently in the process of being patented by the manufacturer, PharmaMar [1].

A study published in the Journal of Clinical Oncology found that lurbinectedin demonstrated promising results in the treatment of SCLC, with an overall response rate of 35% [2]. However, the study also noted that the drug was associated with a high rate of adverse events, including hematologic toxicity and fatigue [2].

In conclusion, lurbinectedin is a new drug that has been approved by the FDA for the treatment of metastatic SCLC. However, it is only available through a restricted program called the ZEPHYRUS program. The drug is not yet available in all countries, but it has been approved in the European Union under the brand name Zepsyre. A study has found that lurbinectedin demonstrated promising results in the treatment of SCLC, but it was associated with a high rate of adverse events.

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