Arranon

Nelarabine injection
GLAXOSMITHKLINENew therapy approved for leukemia and lymphoma

The prodrug of a cytotoxic deoxyguanosine analogue, nelarabine inhibits DNA synthesis and leads to cell death. Nelarabine was approved on October 28, 2005, for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.

Efficacy. The safety and efficacy of nelarabine in the treatment of pediatric patients were evaluated in a study of 84 subjects aged ≤21 years. Patients were treated with 650 mg/m² /d of nelarabine administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days. Complete response (CR) was defined as bone marrow blast counts ≤5%, no other evidence of disease, and full recovery of peripheral blood counts. Complete response without full hematologic recovery (CR*) was also assessed in the study. Of 39 patients who had received at least 2 prior induction regimens, 23% (95% CI, 11%–39%) achieved either CR or CR*. Another study conducted evaluated the safety and efficacy of nelarabine in 39 adult patients who received 1,500 mg/m² of nelarabine administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days. Of 28 patients with leukemia or lymphoma that had relapsed following or was refractory to at least 2 prior induction regimens, 21% (95% CI, 8%–41%) achieved either CR or CR*.

Dosing. The recommended dose of nelarabine in adults is 1,500 mg/m² administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days. The recommended dose of nelarabine in pediatric patients is 650 mg/m² administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days.