FDA drug approval summary: nelarabine for the treatment of T-Cell lymphoblastic leukemia/lymphoma
Cohen MH et al. - In a study to describe the clinical trials leading to FDA approval of nelarabine for the treatment of pts with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens, on October 28, 2005, the FDA granted accelerated approval for nelarabine for treatment of pts with relapsed or refractory T-ALL/T-LBL after at least 2 prior regimens Methods- 2 phase II trials, 1 conducted in pediatric pts and the other in adult pts, were reviewed
- Pts were in their first or subsequent relapse and/or were refractory to first-line therapy
- The dose and schedule of i.v. nelarabine in the pediatric and adult studies were 650 mg/m2 per day daily for 5 days and 1500 mg/m2 i.v. on days 1, 3, and 5, respectively
- Treatments were repeated every 21 days
- Study endpoints were the rates of complete response (CR) and CR with incomplete hematologic or bone marrow recovery (CR*)
Results- Pediatric efficacy population consisted of 39 pts who had relapsed after, or had been refractory to, 2 or more induction regimens
- CR to nelarabine treatment was observed in 5 pts and CR+CR* was observed in 9 pts
- The adult efficacy population consisted of 28 pts
- CR to nelarabine treatment was observed in 5 patients and CR+CR* was observed in 6 pts
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