China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for golidocitinib, a first-in-class JAK1 inhibitor. The drug candidate is filed for the initial indication of treating recurrent refractory peripheral T-cell lymphoma (r/r PTCL).
Supporting Data from the JACKPOT8 Study
The NDA filing is supported by data from one part of the global multi-center pivotal JACKPOT8 study. In this study, golidocitinib demonstrated a 44.3% objective response rate (ORR), meeting the primary endpoint, and a 23.9% complete remission (CR) rate. Tumor responses were observed across multiple common subtypes of PTCL, indicating the drug’s potential efficacy in treating this disease. In terms of safety, treatment-related adverse events (TRAEs) were mostly recoverable or clinically manageable, suggesting a favorable safety and tolerability profile for golidocitinib.
Golidocitinib’s Global Status and Potential Impact
Golidocitinib stands as the world’s first and currently only JAK1 inhibitor at the regulatory clinical stages. It was granted fast-track status in the US in 2022, highlighting its potential significance in the global fight against r/r PTCL. The acceptance of the NDA by the NMPA marks a crucial step towards potentially bringing this innovative treatment to patients in China and beyond.-Fineline Info & Tech
