Pharma Focus Asia

Dizal's Golidocitinib New Drug Application Accepted in China

Friday, September 15, 2023

Dizal has announced that the Centre 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). 

Golidocitinib, as a first-in-class JAK1-only inhibitor, has demonstrated a superior efficacy and safety profile, offering a much-needed treatment option for patients with this challenging disease.

The JAK/STAT signaling pathway is crucial in the development and advancement of several hematologic malignancies, including T-cell malignancies. Golidocitinib, is currently the only inhibitor in the NDA stage for r/r PTCL, demonstrating considerable promise in restraining tumor growth and proliferation through its precise targeting of the JAK/STAT pathway.

Golidocitinib has demonstrated robust and durable anti- tumour activity, as evidenced by an objective response rate (ORR) of 44.3 percent and a complete response rate (CRR) of 23.9 percent. 

These findings indicate that golidocitinib holds substantial promise as an innovative and effective therapeutic option for individuals battling relapsed or refractory peripheral T-cell lymphoma, potentially offering an improved outcomes and hope for better quality of life.

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