Dizal's JAK1 drug gets China nod for peripheral T-cell lymphoma

2024-06-19

上市批准加速审批临床结果

Chinese regulators have approved Dizal's JAK1 inhibitor golidocitinib for adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

The decision makes it "the world's first JAK1-only inhibitor" for PTCL patients, noted CEO Xiaolin Zhang, as well as the second approved drug from Dizal after the AstraZeneca spinout's lung cancer treatment sunvozertinib was waved through in China last year.

While a few drugs have been granted conditional regulatory approvals in the relapsed or refractory PTCL setting, Dizal noted that their single-agent activities have been "modest," with objective response rates (ORRs) below 30%.

During an advisory panel meeting last November, the FDA raised questions about accelerated approvals for Acrotech Biopharma's folate analogue inhibitor Folotyn folate analogue inhibitor Folotyn (pralatrexate) and HDAC inhibitor Beleodaq (belinostat) in relapsed/refractory PTCL after both their confirmatory trials experienced major delays.

However, Dizal says its drug has demonstrated "superior and durable" clinical benefits in the pivotal JACKPOT8B study, compared with these existing treatment options. Data from the trial presented last year showed an ORR of 44.3% with golidocitinib, including a 23.9% complete response rate.

Median duration of response was 20.7 months and 53.8% of patients were still responding. Moreover, tumour responses were observed across various PTCL subtypes. Results of the JACKPOT8 trial have been published in Annals of Oncology and The Lancet Oncology.

"With > 200 to 400-fold selectivity over other JAK family members and ideal pharmacokinetic properties, golidocitinib exerts potent antitumour efficacy with a favourable safety profile," the company said.

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