Golidocitinib Granted Priority Review by China NMPA for the Treatment of r/r PTCL

2023-09-21 20:26 1121

SHANGHAI, Sept. 21, 2023 /PRNewswire/ -- Dizal announced today that the China National Medical Products Administration (NMPA) has granted priority review status to golidocitinib, Dizal's investigational JAK1-only inhibitor, for the treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). In February 2022, golidocitinib received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the same indication, making it the first and only innovative drug in China to receive this recognition for PTCL.

"Patients with relapsed or refractory PTCL worldwide face limited treatment options and a poor prognosis. We are pleased with the CDE's decision to grant priority review status to golidocitinib, as it recognizes the potential of this groundbreaking drug to improve survival benefits for this underserved patient population. We are fully committed to expediting the NDA filing process and ensuring that golidocitinib becomes available to Chinese patients as quickly as possible." said Xiaolin Zhang, PhD, Chairman and CEO of Dizal.

Golidocitinib, a JAK1-only inhibitor, aimed to address the r/r PTCL dilemma

PTCL is an aggressive non-Hodgkin lymphoma (NHL) that represents approximately 7% to 10% of NHLs worldwide. Patients with r/r PTCL face a poor prognosis, with a 3-year survival rate ranging from 21% to 28%. Currently, there is no established consensus on the standard approach for treating r/r PTCL. Therefore, there is an urgent need for novel and innovative treatment options to improve survival in this patient population.

The Priority Review designation for golidocitinib's application was 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, highlighting the superior efficacy and safety of golidocitinib, have been widely acknowledged at prestigious conferences such as ASCO, EHA, ICML, and ASH 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).

Driving innovation through the fundamentals of translational science

Dizal, a spinoff of AstraZeneca's oncology translational science center, has established a portfolio of five clinical-stage assets with global competitiveness. Among these, golidocitinib represents a major research achievement deeply rooted in the principles of translational science. Dizal was the first to identify and validate the JAK/STAT pathway as a highly promising therapeutic approach for PTCL, leading to the development of golidocitinib as the world's first and currently the only JAK1-only inhibitor in pivotal trial for T cell lymphoma.

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 and granted the Priority Review status 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).

About Dizal

Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs around the world. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies and one already launched.

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Source: Dizal Pharmaceutical
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