The FDA approved calaspargase pegol-mknl, an asparagine-specific enzyme, for the treatment of pediatric and young adult patients (ages 1 month to 21 years) with acute lymphocytic leukemia (ALL). The agent was approved as part of a multi-agent chemotherapeutic regimen.
The approval was based on pharmacokinetic data demonstrating that calaspargase pegol-mknl achieved and maintained a nadir serum asparaginase activity above the level of 0.1 U/mL in 124 patients with B-cell ALL. The agent was delivered intravenously at doses of 2,500 U/m2 every three weeks. Compared with other available pegaspargase products, calaspargase pegol-mknl allows for a longer interval between doses.
The most common grade â‰¥3 AEs (occurring in â‰¥10% of participants) included elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting studies. Results from a randomized trial demonstrated that calaspargase pegol-mknl administered every three weeks had a similar safety profile to pegaspargase administered every two weeks.
Calaspargase pegol-mknl received FDA orphan-product designation.
Source: FDA news release, December 20, 2018.