Lurbinectedin is a chemotherapy drug that has been recently approved by the US Food and Drug Administration (FDA) for the treatment of metastatic small cell lung cancer (SCLC) [3]. The drug is a selective inhibitor of RNA polymerase II, an enzyme that plays a crucial role in the transcription of DNA to RNA. It is believed that by inhibiting this enzyme, lurbinectedin can prevent the proliferation of cancer cells [2].

According to a clinical trial published in The Lancet Oncology, lurbinectedin has shown promising results in the treatment of SCLC. The trial involved 105 patients with relapsed SCLC who had previously received platinum-based chemotherapy. The patients were treated with lurbinectedin, and the results showed an overall response rate of 35%, with a median duration of response of 5.3 months. The trial also reported a manageable safety profile, with the most common adverse events being myelosuppression, fatigue, and nausea [2].

Lurbinectedin has been granted accelerated approval by the FDA based on the results of this trial. Accelerated approval is a process that allows drugs to be approved based on surrogate endpoints, such as response rate, rather than overall survival. However, the drug's manufacturer is required to conduct further trials to confirm the drug's clinical benefit [3].

In conclusion, lurbinectedin is a chemotherapy drug that has recently been approved by the FDA for the treatment of metastatic SCLC. The drug has shown promising results in a clinical trial, with an overall response rate of 35% and a manageable safety profile. However, further trials are required to confirm the drug's clinical benefit [2][3].

Sources:
[2] Trigo J, Subbiah V, Besse B, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. The Lancet Oncology. 2020;21(5):645-654. doi:10.1016/S1470-2045(20)30068-1
[3] FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer. US Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer. Published June 15, 2020. Accessed November 9, 2021.
[6] Lurbinectedin - Generic Drug Details. DrugPatentWatch. https://www.drugpatentwatch.com/p/tradename/LURBINECTEDIN. Accessed November 9, 2021.