Dizal has introduced golidocitinib as a pioneering treatment specifically for adult patients suffering from relapsed or refractory (r/r) peripheral T-cell lymphoma (PTCL), a form of aggressive non-Hodgkin lymphoma characterised by T-cell and natural killer (NK) cell origins.
This medication, the first Janus kinase 1 (JAK1) selective inhibitor approved globally for r/r PTCL, targets patients whose disease has progressed despite prior systemic therapy.
PTCL represents a diverse group of lymphomas where patients often experience high rates of disease recurrence, even after achieving initial remission with standard therapies. For those who relapse or are refractory, prognosis is notably poor, with a median overall survival of just 5.8 months and a 3-year survival rate of 23 percent.
While a few drugs have received conditional approval for r/r PTCL, their efficacy as single agents has been limited, with objective response rates (ORRs) below 30 percent.
Approval of golidocitinib was supported by data from the multinational JACKPOT8 Part B (JACKPOT8B) study, a pivotal trial evaluating its effectiveness and safety as a monotherapy in r/r PTCL. The primary measure of success was the objective response rate (ORR), as assessed by an independent review committee (IRC).
Golidocitinib stands out due to its innovative mechanism of action and unique molecular design, making it the first oral JAK1 inhibitor tailored specifically for treating r/r PTCL. Multiple studies have confirmed its favourable pharmacokinetic profile and significant clinical benefits.