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FDA approves Asparlas for acute lymphoblastic leukemia
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The FDA today approved calaspargase pegol-mknl as part of a multiagent chemotherapeutic regimen for pediatric and young adult patients with acute lymphoblastic leukemia.
Calaspargase pegol-mknl (Asparlas, Servier Pharmaceuticals) is an asparagine specific enzyme that is proven to have a longer interval between doses compared with other approved pegaspargase products.
The corresponding study that supported the approval analyzed the drug with multiagent chemotherapy in 124 patients with B-cell lineage ALL.
The approval also was based on the drug’s achievement and maintenance of nadir serum asparaginase activity above 0.1 U/mL when using calaspargase pegol-mknl at 2,500 U/m2 every 3 weeks.
Adverse events during the trial included elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting. All adverse events were grade 3 or lower.
The recommended dose is 2,500 units/m2 administered intravenously every 3 weeks.