PharmaMar announced the Swiss Agency for Therapeutic Products (Swissmedic) has granted Orphan Drug designation to lurbinectedin for the treatment of Small Cell Lung Cancer (SCLC).
This decision is based on the orphan drug recognition granted by the European Medicines Agency on February 26th, 2019.
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SCLC is PharmaMar's priority research area. On August 19th it was announced that the Company will file lurbinectedin’s NDA for the treatment of relapsed SCLC with the FDA in the United States under the “accelerated approval” program during the last quarter of this year. This would open up the possibility for the FDA to approve lurbinectedin in the U.S. for the treatment of relapsed SCLC within the next year.
The ATLANTIS phase III trial of lurbinectedin in combination with doxorubicin for the treatment of this same type of tumor ended patient recruitment in July 2018 and is expected to have Overall Survival results in 2020.