FDA Grants Dizal Fast Track Designation for Lymphoma Therapy

The U.S. Food and Drug Administration granted Dizal Pharmaceutical Fast Track designation to DZD4205 (Golidocitinib) for the treatment of patients with refractory or relapsed peripheral T-cell lymphoma.

Photo: Xiaolin Zhang, CEO at Dizal

Relapsed or refractory peripheral T-cell lymphoma is an aggressive and rare type of non-Hodgkin lymphoma. Patients with r/r PTCL are often associated with poor prognosis.

DZD4205 (Golidocitinib) is an orally available, potent, and JAK1-specific inhibitor. The preliminary data from an ongoing phase 1/2 study in r/r PTCL shows that 21 (42.9 percent) out of the 49 patients have achieved tumor response. Dizal is conducting phase 2 pivotal clinical trials in the U.S., China, Australia, South Korea and other countries and regions.

“Our translational science team first identified JAK1 as a potential target for PTCL treatment. Based on the finding, we launched clinical studies to test the hypothesis,” said Xiaolin Zhang, CEO at Dizal. “Now, we have patient data which validated our translational science finding. This is a great example of translational science-driven drug development.”

Fast track is a process designed by U.S. FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

Author: Rare Daily Staff