FDA grants Orphan Drug Designation to cerdulatinib for the treatment of peripheral T-cell lymphoma

On 25 September 2018, the US Food and Drug Administration (FDA) granted Orphan Drug Designation to cerdulatinib, an oral Syk/JAK inhibitor, for the treatment of peripheral T-cell lymphoma (PTCL).

SYK is a key regulator of BCR signaling and it is also expressed in PTCL. Preclinical studies suggest that SYK may be an oncogenic driver for PTCL. Cerdulatinib is a selective and potent inhibitor of SYK, JAK1, JAK3, and TYK2.

At present, cerdulatinib is being evaluated in an ongoing phase IIb study (NCT01994382), which is assessing the efficacy and safety of cerdulatinib in patients with relapsed or refractory B- and T-cell lymphoma. Interim data presented at the 23rd Congress of the European Hematology Association (EHA) demonstrated that cerdulatinib exhibited broad clinical activity and was well tolerated.  Seven of the 20 patients in the PTCL cohort achieved a complete response at the time of presentation.

  1. Portola Pharmaceuticals: Portola Pharmaceuticals Receives FDA Orphan Drug Designation for Cerdulatinib, an Oral Syk/JAK Inhibitor for the Treatment of Peripheral T-Cell Lymphoma. 2018 Sep 25. [Accessed 2018 Oct 09].
  2. Hamlin P. A. et al. The dual SYK/JAK inhibitor cerdulatinib demonstrates rapid tumor responses in a phase 2a study in patients with relapsed/refractory B- and T-cell non- Hodgkin lymphoma (NHL). Abstract #PF437 23rd Congress of the European Hematology Association (EHA).
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