Dizal’s JAK1 Inhibitor NDA Accepted for China Review as PTCL Therapy
publication date: Sep 15, 2023
Shanghai Dizal Pharma reported its NDA for golidocitinib was accepted by China’s CDE for review as a treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). Golidocitinib is a first-in-class Janus kinase 1 (JAK1) only inhibitor that showed efficacy in a global, multicenter pivotal study. In a trial that enrolled 112 r/r PTCL patients, golidocitinib produced an ORR of 44% and a CRR of 24%. One month ago, Dizal announced that its lead drug, sunvozertinib, was approved for China use as a second line therapy for NSCLC with EGFR exon 20 insertion mutations. More details....
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