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03/29/2019 - 07:00

FDA approves Asparlas ( calaspargase pegol-mknl )

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.

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.

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.

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

ASPARLAS is used in combination with other drugs for the treatment of acute lymphoblastic leukemia (ALL) in patients 1 month to 21 years old.

ALL is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of lymphocytes (a type of white blood cells) in the bloodstream.

How is this drug used?

ASPARLAS is given by a healthcare provider directly into the bloodstream through a needle in the vein (known as an intravenous or IV infusion) no more frequently than every 21 days. It takes about one hour to receive an ASPARLAS infusion.

What are the benefits of this drug?

Leukemia cells depend on asparagine in the blood for survival. Without adequate blood levels of asparagine, leukemia cells die.

Ninety-nine percent of the 123 patients who received ASPARLAS demonstrated removal of asparagine from the blood at 6, 12, 18, 24, and 30 weeks after treatment.

Source

URL: https://www.fda.gov/Drugs/InformationOnDrugs/ucm629352.htm

URL: https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100310/asparlas-calaspargase-pegol-mknl-

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