China NMPA approves Dizal’s golidocitinib for PTCL treatment
20 Jun 2024
Fast TrackDrug ApprovalClinical Result
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Source: Pharmaceutical Technology
PTCL represents a diverse group of aggressive non-Hodgkin lymphomas, with patients at a high risk of disease relapse. Credit: Nemes Laszlo / Shutterstock.
The National Medical Products Administration (NMPA) of China has approved Dizal’s golidocitinib for adults with relapsed or refractory (r/r) peripheral T-cell lymphoma (PTCL).
This is the first global approval of a Janus kinase 1 (JAK1) selective inhibitor for r/r PTCL patients whose disease has advanced following a minimum of one previous systemic therapy or who were refractory to this.
PTCL represents a diverse group of aggressive non-Hodgkin lymphomas, with patients at a high risk of disease relapse.
The approval is based on the data from the multinational JACKPOT8 Part B study to assess the safety and efficacy of golidocitinib monotherapy in r/r PTCL patients.
Objective response rate (ORR) was the trial’s primary endpoint.
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Golidocitinib offered superior and lasting antitumor efficacy and had a favourable safety profile versus current treatments.
The ORR was 44.3% with a complete response rate of 23.9%, according to an independent review committee.
Notably, 53.8% of patients were still responding at the time of the analysis.
Dizal CEO Xiaolin Zhang said: “We are thrilled to bring golidocitinib, the world’s first JAK1-only inhibitor, to patients in China, marking the second approved innovative drug from Dizal.
“Golidocitinib yields good antitumour efficacy across different subtypes of PTCL, which differentiate golidocitinib from other targeted therapies. At Dizal, we aspire to discover and develop first-in-class and groundbreaking new medicines to address unmet medical needs around the world. With the US FDA fast track designation, we are expediting global development of golidocitinib to bring this exciting drug to patients worldwide.”
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