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FDA Grants Lurbinectedin Orphan Drug Status for SCLC

Jason M. Broderick @jasoncology
Published: Monday, Aug 06, 2018

Luis Mora Capitan

Luis Mora Capitan
The FDA has granted lurbinectedin (PM1183) an orphan drug designation for the treatment of patients with small cell lung cancer (SCLC), according to PharmaMar, the manufacturer of the marine-derived treatment.

Lurbinectedin is currently being studied in the global, randomized, phase III ATLANTIS study with doxorubicin versus investigator’s choice of either cyclophosphamide, doxorubicin and vincristine or topotecan (NCT02566993). ATLANTIS is actively recruiting for patients with SCLC who have failed 1 prior platinum-containing line of therapy.
Perez JMT, Leary A, Besse B, et al. Efficacy and safety of lurbinectedin (PM1183) in small cell lung cancer (SCLC): Results from a phase 2 study. J Clin Oncol. 2018;36 (suppl; abstr 8570).

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