National Stroke Foundation

Asparlas (calaspargase pegol-mknl )

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved December 2018

Specific Treatments:

acute lymphoblastic leukemia in pediatrics and young adults

General Information

Asparlas is an asparagine specific enzyme. 

Asparlas is specifically indicated as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years.

Asparlas is supplied as an injection for intravenous administration. The recommended dosage is 2,500 units/m2 intravenously no more frequently than every 21 days.

Clinical Results

FDA Approval

The FDA approval of Asparlas was based on a demonstration of the achievement and maintenance of nadir serum asparaginase activity (NSAA) above the level of 0.1 U/mL using Asparlas 2500 U/m2 intravenously every 3 weeks. The pharmacokinetics of Asparlas were studied when used in combination with multiagent chemotherapy in 124 patients with B cell lineage acute lymphoblastic leukemia (ALL). The results showed that 123 (99%) of the 124 patients maintained NSAA > 0.1 U/mL at weeks 6, 12, 18, 24 and 30.

Side Effects

Adverse effects associated with the use of Asparlas may include, but are not limited to, the following:

elevated transaminase

increased bilirubin

pancreatitis

abnormal clotting

Mechanism of Action

Asparlas is an asparagine specific enzyme. L-asparaginase is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The pharmacological effect of Asparlas is thought to be based on selective killing of 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.

Additional Information

For additional information regarding Asparlas or acute lymphoblastic leukemia in pediatrics and young adults, please visit https://servier.com/en/