On September 14, 2023 Dizal reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for golidocitinib for the treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) (Press release, Dizal Pharma, SEP 14, 2023, View Source [SID1234635170]).
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"We are thrilled that our NDA for golidocitinib has been accepted, marking our second successful NDA submission in 2023," said Xiaolin Zhang, Ph.D., Chairman and CEO of Dizal, "Golidocitinib, as a first-in-class JAK1-only inhibitor, has demonstrated a superior efficacy and safety profile. We believe it will provide a much-needed treatment option for patients with this challenging disease. At Dizal, we aspire to discover and develop differentiated therapeutics for the treatment of cancer and immunological diseases."
The JAK/STAT signaling pathway plays a vital role in the pathogenesis and progression of various hematologic malignancies, including T-cell malignancies. Golidocitinib, as the first and currently the only JAK1-only inhibitor in the NDA stage for r/r PTCL, shows promising potential in inhibiting tumor growth and proliferation by targeting the JAK/STAT pathway.
The NDA submission for golidocitinib is supported by data from the JACKPOT8 PARTB study, a multinational, pivotal study to evaluate the efficacy and safety of golidocitinib in patients with r/r PTCL. The primary endpoint of the study, objective response rate (ORR) assessed by an independent review committee (IRC), reached 44.3%, with a complete response rate (CRR) of 23.9%. Anti-tumor efficacy was observed across different PTCL subtypes and irrespective of the patients’ prior treatment history. The majority of treatment-related adverse events (TRAEs) could be monitored and well managed in the clinic. These findings highlight the superior efficacy and safety of golidocitinib, positioning it as a potential breakthrough therapy for patients with r/r PTCL. Furthermore, the clinical significance of golidocitinib has been widely acknowledged at prestigious conferences such as ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper), ICML, and ASH (Free ASH Whitepaper) with five oral presentations for four consecutive years. Recently, the Phase I clinical data of golidocitinib for the treatment of r/rPTCL (JACKPOT8 PARTA) was published in the esteemed peer-reviewed journal, Annals of Oncology (Impact Factor: 51.8).
About golidocitinib (DZD4205)
Golidocitinib is the first-in-class Janus kinase 1 (JAK1) only inhibitor currently being evaluated in a global, multicenter pivotal study (JACKPOT8 PARTB) in r/r PTCL. At the data cut-off date of February 16, 2023, Golidocitinib has demonstrated robust and durable anti-tumor activity, with an ORR of 44.3% and a CRR of 23.9%. More than 50% of the patients with tumor remission achieved a complete response. The median relative dose intensity was 100%. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted the NDA for the treatment of r/r PTCL. And the Phase I clinical data of golidocitinib for the treatment of r/r PTCL (JACKPOT8 PARTA) was published in Annals of Oncology (Impact Factor: 51.8).