BRIEF—FDA approves Servier's Asparlas for ALL

The US Food and Drug Administration approved calaspargase pegol-mknl, brand name Asparlas, from privately-held French drugmaker Servier.

Asparlas is an asparagine specific enzyme, and is approved 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.

Servier acquired the product from Ireland-based Shire, as part of its $2.4 billion buy of Shire’s oncology business earlier this year.

This new product provides for a longer interval between doses compared to other available pegaspargase products.

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.