The U.S. Food and Drug Administration approved calaspargase pegol-mknl as part of a multi-agent chemotherapy regimen for the treatment of pediatric and young adult patients with acute lymphocytic leukemia (ALL). This asparagine-specific enzyme allows for a longer interval between doses compared with other pegylated asparaginase products.
The agency’s approval was based on results from a multicenter study that enrolled 124 patients with B-cell lineage ALL. Patients treated with calaspargase pegol-mknl were able to achieve and maintain a nadir serum asparaginase activity above 0.1 U/mL. The recommended dose of calaspargase pegol-mknl is 2,500 units/m2, administered intravenously at a minimum dosing interval of every 21 days.
The safety profile of calaspargase pegol-mknl, when administered every three weeks, was similar to that of pegaspargase administered every three weeks, and the most common grade ≥3 adverse events were elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting studies.
Source: FDA news release, December 20, 2018.