The Food and Drug Administration (FDA) has approved Asparlas (calaspargase pegol-mknl; Servier) injection as part of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) in patients aged 1 month to 21 years.
Compared with other pegaspargase products (Oncaspar [pegaspargase], Erwinaze [asparaginase Erwinia chrysanthemi]), Asparlas allows for a longer interval between doses. The recommended dosing interval is a minimum of every 21 days. Asparlas contains an asparagine specific enzyme derived from Escherichia coli. The drug works by selectively killing leukemic cells due to depletion of plasma L-asparagine. Leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize L-asparagine, and therefore depend on an exogenous source of L-asparagine for survival.
The FDA approval was supported by data showing the achievement and maintenance of nadir serum asparaginase activity (NSAA) above the level of 0.1 Units/mL with Asparlas 2500 Units/m2 given intravenously (IV) every 3 weeks. The pharmacokinetics of Asparlas were evaluated when given in combination with multiagent chemotherapy in patients with B-cell lineage ALL (N=124). Almost all patients (N=123; 99%) maintained NSAA >0.1 Unit/mL at weeks 6, 12, 18, 24, and 30.
Elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting studies were the most frequently reported grade ≥3 adverse events. The safety profile of Asparlas administered every 3 weeks was comparable to that of pegaspargase administered every 2 weeks.
Asparlas will be available as 3750 Units/5mL (750 Units/mL) strength, preservative-free solution in single-dose vials for IV infusion after dilution.
For more information call (857) 895-4853 or visit Servier.com.