Dizal's JAK1 Drug Approved in China for Peripheral T-Cell Lymphoma

Chinese regulators have given the green light to Dizal's JAK1 inhibitor, golidocitinib, for treating adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This approval marks a significant milestone as it becomes the "world's first JAK1-only inhibitor" for PTCL, according to CEO Xiaolin Zhang. This is also Dizal's second approved drug following the success of its lung cancer treatment, sunvozertinib, which received approval in China last year.

While other drugs have received conditional regulatory approvals for relapsed or refractory PTCL, Dizal pointed out that the efficacy of these single-agent treatments has been modest, with objective response rates (ORRs) under 30%. Notably, during an advisory panel meeting in November, the FDA raised concerns about the accelerated approvals of Acrotech Biopharma's folate analogue inhibitor Folotyn (pralatrexate) and HDAC inhibitor Beleodaq (belinostat) due to significant delays in their confirmatory trials.

In contrast, Dizal asserts that golidocitinib has shown "superior and durable" clinical benefits in its JACKPOT8B study when compared to existing treatments. Data from this pivotal trial, presented last year, revealed an ORR of 44.3% for golidocitinib, including a complete response rate of 23.9%. The median duration of response was 20.7 months, with 53.8% of patients continuing to respond to the treatment. Additionally, tumor responses were noted across various subtypes of PTCL.

The results of the JACKPOT8B trial have been published in reputable journals such as Annals of Oncology and The Lancet Oncology. The company highlighted that golidocitinib has "200 to 400-fold selectivity over other JAK family members," showcasing potent antitumor efficacy and a favorable safety profile. These ideal pharmacokinetic properties contribute to its effectiveness against PTCL.

With the approval of golidocitinib, Dizal aims to offer a new hope for patients with this challenging type of lymphoma. The company continues to focus on delivering innovative treatments that provide significant clinical benefits and improve patient outcomes.