Calaspargase Pegol-mknl Granted FDA Approval for Pediatric, Young Adult Patients With ALL

The FDA has approved calaspargase pegol-mknl (Asparlas, Servier Pharmaceuticals) as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients, aged 1 month to 21 years. This new product, an asparagine specific enzyme, provides for a longer interval between doses compared to other available pegaspargase products.

Calaspargase pegol-mknl received the FDA’s orphan product designation. According to the agency, the product’s approval was based on a demonstration of the achievement and maintenance of nadir serum asparaginase activity above the level of 0.1 U/mL when using calaspargase pegol-mknl, 2500 U/m2 intravenously, every 3 weeks. The pharmacokinetics of calaspargase pegol-mknl were studied when administered in combination with multiagent chemotherapy in 124 patients with B-cell lineage ALL.

The most common (incidence ≥ 10%) grade ≥ 3 adverse reactions were elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting studies. In a randomized trial, the safety profile of calaspargase pegol-mknl administered every 3 weeks was similar to that of pegaspargase administered every 2 weeks.

The recommended calaspargase pegol-mknl dose is 2,500 units/m2 intravenously administered at a minimum dosing interval of every 21 days.

Reference

FDA approves longer-acting calaspargase pegol-mknl for ALL [news release]. Silver Spring, MD; December 20, 2018: FDA website. http://www.pharmacytimes.com/link/240?rel=0" . Accessed December 21, 2018.