News

FDA Approves Asparagine Specific Enzyme for Use in Multiagent ALL Chemo Regimen

12/20/2018

The FDA has approved calaspargase pegol-mknl (Asparlas; Servier Pharmaceuticals) for use in a multiagent chemotherapy regimen for the treatment of patients aged 1 to 21 years with acute lymphoblastic leukemia (ALL).

Calaspargese pegol-mnkl, an asparagine specific enzyme, provides for a longer interval between doses compared with other pegaspargase-based therapies.

This approval was based on a evidence of madir serum asparaginase activity > 0.1 U/mL being achieved and maintained with calaspargase pegol-mknl 2500 U/m2 administered intravenously every 3 weeks.

The pharmacokinetics of calaspargase pegol-mkni were examined in combination with multiagent chemotherapy in 124 patients with B-cell lineage ALL. In a randomized clinical trial, the safety profile of calaspargase pegol-mknl administered every 3 weeks was found to be similar to that of pegaspargase administered every 2 weeks.

The most common grade ≥3 adverse reactions were elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting studies.—Janelle Bradley

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