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When was lurbinectedin approved by the fda?



Lurbinectedin was granted accelerated approval by the FDA on June 15, 2020, for the treatment of metastatic small cell lung cancer (SCLC) in patients who have received prior treatment.[2][3] The approval was based on the results of a clinical trial that showed a response rate of 35% in patients with SCLC who had previously received chemotherapy.[3] Lurbinectedin is marketed under the brand name Zepzelca and is manufactured by PharmaMar.[1][2] The drug works by inhibiting the activity of RNA polymerase II, an enzyme that is essential for the transcription of DNA into RNA, which is necessary for the growth and survival of cancer cells.[3] As with all drugs, Lurbinectedin may cause side effects, which are listed in the drug's label.[3]

Sources:
[1] https://www.drugpatentwatch.com/p/tradename/LURBINECTEDIN
[2] https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer
[3] https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213702s000lbl.pdf



Follow-up:   What are the benefits of lurbinectedin? What are the side effects of lurbinectedin? How does lurbinectedin work in treating cancer?





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