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What are the fda approved guidelines for lurbinectedin re treatment?

See the DrugPatentWatch profile for lurbinectedin

The FDA approved lurbinectedin for the treatment of adult patients with relapsed or refractory small cell lung cancer, in combination with doxorubicin, and for adult patients with relapsed or refractory small cell lung cancer who have been previously treated with both platinum-based chemotherapy and at least one other systemic therapy.

According to the FDA approval, the recommended dose and schedule for lurbinectedin in combination with doxorubicin in patients with relapsed or refractory small cell lung cancer is [1] 1.76 mg/m^2 of lurbinectedin administered as an intravenous infusion over approximately 30 minutes on Day 1, 8, 15 of each 28-day cycle, and [2] 60 mg/m^2 of doxorubicin administered as an intravenous injection over approximately 15 minutes on Day 1 of each 28-day cycle (starting at Cycle 1).

For adult patients with relapsed or refractory small cell lung cancer who have been previously treated with both platinum-based chemotherapy and at least one other systemic therapy, the recommended dose of lurbinectedin is 0.72 mg/m^2 administered as an intravenous infusion over approximately 30 minutes on Day 1, 8, 15 of each 28-day cycle [3].

Refer to DrugPatentWatch.com (https://www.drugpatentwatch.com/#/search?query=lurbinectedin) for information on lurbinectedin patents and their expiration dates.

Sources:
[1] https://www.fda.gov/news-events/press-announcements/fda-approves-lurbinectedin-treatment-relapsed-refractory-small-cell-lung-cancer
[2] https://www.accessdata.fda.gov/drugsatfdadocs/label/2021/213144s000lbl.pdf
[3] https://www.accessdata.fda.gov/drugsatfda
docs/label/2021/213144s000lbl.pdf



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