Dizal Pharmaceutical Co., Ltd (SHA: 688192), a spin-off from AstraZeneca China established in 2017, has announced that the National Medical Products Administration (NMPA) has granted approval for its drug golidocitinib. The drug is indicated for the treatment of adult patients with relapsed or refractory (r/r) peripheral T-Cell lymphoma (PTCL) who have experienced disease progression on or were refractory to at least one prior systemic therapy. Golidocitinib is currently the first and only approved Janus kinase 1 (JAK1) selective inhibitor for r/r PTCL patients globally.
The NMPA’s approval decision is based on the results of the JACKPOT8 Part B (JACKPOT8B) study, which had the objective response rate (ORR) as its primary endpoint, assessed by an independent review committee (IRC). As of the data cut-off date on August 31, 2023, the ORR was 44.3%, including a complete response (CR) rate of 23.9% according to the IRC. Tumor responses were observed across various PTCL subtypes. In terms of safety, the majority of treatment-related adverse events (TRAEs) were recoverable or clinically manageable, indicating a favorable safety and tolerability profile.
Golidocitinib, which is currently the first and only JAK1 inhibitor under evaluation for the treatment of r/r PTCL, was awarded fast-track status in the U.S. for this indication in February 2022.- Flcube.com
