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Has lurbinectedin been approved for use?



Yes, lutebinectedin has been approved for use. The European Medicines Agency (EMA) approved lutebinectedin, developed by PharmaMar, for the treatment of adult patients with relapsed small cell lung cancer (SCLC) in June 2020 [1]. The US Food and Drug Administration (FDA) granted accelerated approval to lutebinectedin, under the brand name Squibdyl, for the treatment of adults with metastatic SCLC with disease progression on or after platinum-based chemotherapy in February 2021 [2]. Lutebinectedin is a selective inhibitor of DNA binding by oncogenic transcription factors [3].

Sources:
[1] European Medicines Agency. Lurbinectedin: first cancer medicine from marine origin approved in the EU. <https://www.ema.europa.eu/en/news/lurbinectedin-first-cancer-medicine-marine-origin-approved-eu>.
[2] US Food and Drug Administration. FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer. <https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer>.
[3] PharmaMar. Lurbinectedin (PM1183). <https://www.pharmamar.com/en/r-d-portfolio/anticancer-agents-in-clinical-development/lurbinectedin-pm1183>.



Follow-up:   Has lurbinectedin been approved for any cancer types? In what countries is lurbinectedin currently approved? What stage of development is lurbinectedin in clinical trials?





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