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17-06-2020 | FDA | News

approvalsWatch

Lurbinectedin approved for US metastatic SCLC patients

Author:
Lynda Williams

medwireNews: The US FDA has given accelerated approval for use of lurbinectedin in patients with metastatic small-cell lung cancer (SCLC) who have progressed during or after platinum-based chemotherapy.

The decision follows open-label trial findings demonstrating a RECIST investigator-assessed objective response rate of 35.0% to second-line lurbinectedin in this patient population, with responses lasting a median of 5.3 months.

“Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials,” states the FDA announcement.

The recommended dose is 3.2 mg/m2 every 21 days, with the most common adverse events including myelosuppression, fatigue, gastrointestinal symptoms and elevated liver enzymes.

medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group

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