China Approves Dizal’s Golidocitinib for PTCL

The National Medical Products Administration (NMPA) of China has officially approved Dizal’s golidocitinib for adult patients who have either relapsed or have refractory peripheral T-cell lymphoma (PTCL). This announcement marks the first global approval for a Janus kinase 1 (JAK1) selective inhibitor specifically targeting patients whose disease has either relapsed after at least one systemic therapy or who were unresponsive to such treatments.

PTCL is a diverse and aggressive category of non-Hodgkin lymphomas, with a high propensity for disease relapse among patients. The decision for approval was primarily based on the findings from the multinational JACKPOT8 Part B study, which assessed the safety and efficacy of golidocitinib as a monotherapy in patients with relapsed or refractory PTCL. The primary endpoint of this study was the objective response rate (ORR), which indicates the proportion of patients whose tumors showed a significant reduction in size.

The results from the JACKPOT8 Part B study showed that golidocitinib not only provided superior and durable antitumor efficacy but also maintained a favorable safety profile compared to existing treatments. The study revealed an ORR of 44.3% with a complete response rate of 23.9%, as assessed by an independent review committee. These findings are significant, considering the challenging nature of treating PTCL.

Patients across various subtypes of PTCL exhibited a positive response to the treatment, with a median duration of response recorded at 20.7 months. Furthermore, at the time of analysis, 53.8% of the patients were still responding to the treatment, highlighting the long-lasting impact of golidocitinib.

Xiaolin Zhang, the CEO of Dizal, expressed immense satisfaction with the approval, stating, "We are thrilled to bring golidocitinib, the world’s first JAK1-only inhibitor, to patients in China. This marks the second approved innovative drug from Dizal." He further emphasized that golidocitinib demonstrates considerable antitumor efficacy across various PTCL subtypes, setting it apart from other targeted therapies. Zhang also mentioned Dizal's commitment to discovering and developing groundbreaking medicines to meet unmet medical needs globally. With the US FDA fast track designation, the company is accelerating the global development of golidocitinib to make this promising drug accessible to patients worldwide.

In summary, the NMPA's approval of golidocitinib represents a significant advancement in the treatment of relapsed or refractory PTCL. This approval is based on robust clinical data demonstrating the drug's efficacy and safety. With continued efforts to expedite its global availability, golidocitinib holds the potential to offer a new and effective treatment option for PTCL patients who have limited alternatives.