FDA Approves Asparlas for ALL in Children and Young Adults

The U.S. Food and Drug Administration (FDA) announced approval of AsparlasTM for acute lymphoblastic leukemia (ALL) on December 20, 2018.1,2

What is Asparlas?

Asparlas is a longer-acting calaspargase pegol-mknl, an asparagine specific enzyme, as a component of a multi-drug chemotherapy regimen for ALL in pediatric and young adult patients age 1 month to 21 years. This newly approved drug provides for a longer interval between doses, as compared to other available pegaspargase products.

Approval of Asparlas was based on a demonstration of the achievement and maintenance of nadir serum asparaginase activity above the level of 0.1 U/mL when using Asparlas, 2500 U/m2 intravenously, every 3 weeks. Asparlas was studied when administered in combination with multi-drug chemotherapy in 124 patients with B-cell lineage ALL.

The most common adverse reactions were elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting studies. In a randomized trial, the safety profile of Asparlas given every 3 weeks was similar to that of pegaspargase given every 2 weeks.1

Dosing information

The recommended dose of Asparlas is 2,500 units/m2 intravenously administered at a minimum dosing interval of every 21 days. The full prescribing information for Asparlas can be found by clicking here.1,2

View References
  1. FDA approves longer-acting calaspargase pegol-mknl for ALL. The U.S. Food and Drug Administartion. Available at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm628980.htm
  2. ASPARLASTM (calaspargase pegol - mknl) Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761102s000lbl.pdf