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Orphan drug designation granted to SLS009 for the treatment of R/R peripheral T-cell lymphoma

By Abhilasha Verma

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Aug 7, 2024

Learning objective: After reading this article, learners will be able to cite a new clinical development in T-cell lymphoma.


On August 6, 2024, the European Medicines Agency (EMA) granted orphan drug designation to SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL).1

This announcement is based on key results from the phase I (NCT04588922) clinical trial, which demonstrated favorable safety/tolerability and promising clinical efficacy of SLS009 in patients with R/R hematological malignancies.  The PTCL patient group achieved a response rate of 36.4%, including one patient who remained in continuous treatment for over 56 weeks.1

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