The National Medical Products Administration (NMPA) in China has approved golidocitinib for treatment of relapsed or refractory peripheral T-Cell lymphoma (PTCL) in adult patients.
Golidocitinib is an oral Janus kinase 1 (JAK1) selective inhibitor under development by Dizal Pharmaceutical. It is the first such agent to be approved for relapsed or refractory PTCL anywhere in the world.
The NMPA approval was based on the results from the multinational JACKPOT8 Part B study, which were published in Annals of Oncology and The Lancet Oncology. The study’s researchers found that the efficacy and safety profile of golidocitinib monotherapy compared favorably against current treatments for relapsed or refractory PTCL.
In February 2022, the US Food and Drug Administration granted golidocitinib Fast Track Designation for treatment of relapsed or refractory PTCL in the United States.