The Food and Drug Administration (FDA) has granted Orphan Drug designation to cerdulatinib (Portola Pharmaceuticals), an investigational treatment for peripheral T-cell lymphoma (PTCL). 

Cerdulatinib is a dual spleen tyrosine kinase (Syk) and janus kinase (JAK) inhibitor; both targets have been shown to promote cancer cell growth and survival. In addition, preclinical data has suggested that Syk and JAK play important roles in PTCL tumor survival.

Cerdulatinib is currently being examined in a Phase 2a study in patients with B- and T-cell Non-Hodgkin lymphoma, including relapsed/refractory follicular lymphoma and chronic lymphocytic lymphoma/small lymphocytic lymphoma. Interim results presented in June 2018 showed that cerdulatinib demonstrated broad clinical activity including an objective response rate of 47% in all patients. Moreover, 7 of the 20 patients in the PTCL cohort achieved a complete response at the time of presentation.  

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“We look forward to presenting additional data from the Phase 2a trial at a scientific congress early next year and to continuing discussions with the FDA regarding next steps for the development of cerdulatinib, including the potential for an accelerated approval pathway,” said John Curnutte, MD, PhD, Portola’s head of R&D.

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