Dizal has gained approval in China for its Janus kinase 1 (JAK1) selective inhibitor golidocitinib in relapsed or refractory peripheral T-Cell lymphoma (PTCL) in adults.
The Chinese National Medical Products Administration (NMPA) has approved the drug for the treatment of patients whose condition has advanced on or were refractory to at least one prior systemic therapy.
Golidocitinib is now claimed to be the first and only approved JAK1 selective inhibitor for r/r PTCL patients globally.
The NMPA approval was based on data from the JACKPOT8 Part B (JACKPOT8B) study, a multinational pivotal trial evaluating golidocitinib’s efficacy and safety as a monotherapy in relapsed or refractory PTCL.
The study’s primary endpoint, objective response rate (ORR) assessed by an independent review committee (IRC), demonstrated superior and durable anti-tumour efficacy compared to existing treatment options.
As of 31 August 2023, the ORR was 44.3%, with a complete response (CR) rate of 23.9% per IRC.
The tumour responses were observed across various PTCL subtypes.
The median duration of response (mDoR) was 20.7 months, and 53.8% of patients were still responding, said Dizal, a Chinese biopharmaceutical company focused on developing differentiated therapeutics for cancer and immunological diseases.
Golidocitinib had previously received fast track designation from the US Food and Drug Administration (FDA) in February 2022.
The JAK1 selective inhibitor underwent priority review for its new drug application (NDA) for the treatment of relapsed or refractory PTCL after it was accepted by China’s Center for Drug Evaluation (CDE) in September 2023.
Dizal CEO Xiaolin Zhang said: “Golidocitinib yields good anti-tumour efficacy across different subtypes of PTCL, which differentiate golidocitinib from other targeted therapies.
“At Dizal, we aspire to discover and develop first-in-class and groundbreaking new medicines to address unmet medical needs around the world. With the US FDA Fast Track designation, we are expediting global development of golidocitinib to bring this exciting drug to patients worldwide.”
Golidocitinib is the second drug of Dizal to have been approved after Sunvozertinib, which is indicated in China for the treatment of advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon20ins after platinum-based chemotherapies.
