China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its drug golidocitinib has been included in the priority review list for the treatment of recurrent or refractory peripheral T-cell lymphoma (r/r PTCL) in patients who have received at least one standard treatment. The priority status indicates the drug’s filing as a conditional approval product, highlighting its potential significance in addressing unmet medical needs.
Golidocitinib: A Pioneering JAK1 Inhibitor
Golidocitinib is recognized as the world’s first and currently only JAK1 inhibitor at the regulatory clinical stages. It obtained fast-track status in the US in 2022, underscoring its global potential in treating certain cancers. The drug’s latest data from the global multi-center regulatory study for r/r PTCL was presented at the 2023 ASCO annual meeting, demonstrating promising results.
Positive Clinical Data and Anti-Tumor Efficacy
In the study involving 88 patients who failed standard treatment, the objective response rate (ORR) confirmed by the Independent Review Committee (IRC) was 44.3%. Notably, 21 patients achieved a complete response (CRR: 23.9%), indicating that golidocitinib’s anti-tumor efficacy covers multiple common pathological subtypes of PTCL. These results support the drug’s potential role in improving outcomes for patients with r/r PTCL and reinforce its inclusion in the priority review list.-Fineline Info & Tech
