FDA approves calaspargase pegol-mknl in pediatric ALL


  • David Reilly
  • Oncology drug update
Der Zugang zum gesamten Inhalt dieser Seite ist nur Angehörigen medizinischer Fachkreise vorbehalten. Der Zugang zum gesamten Inhalt dieser Seite ist nur Angehörigen medizinischer Fachkreise vorbehalten.

Takeaway

  • On December 20, 2018, the FDA approved calaspargase pegol-mknl as a component of a multiagent chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to 21 years.
  • Recommended dosing for calaspargase pegol-mknl is 2500 units/m2 intravenously at a minimum dosing interval of 21 days.  

Why this matters

  • The approval of this asparagine-specific enzyme realizes a longer interval between doses vs other pegaspargase products.

Study design

  • The approval was based on results of a study to demonstrate the achievement and maintenance of nadir serum asparaginase activity (NSAA) >0.1 U/mL with intravenous administration of calaspargase pegol-mknl 2500 U/m2 every 3 weeks in 124 pediatric patients with B-cell lineage ALL.
  • Median patient age: 11.5 years (range, 1-26 years).
  • Funding: Servier Pharmaceuticals LLC.

Key results

  • 99% (95% CI, 96%-100%) of patients maintained NSAA >0.1 U/mL at weeks 6, 12, 18, 24, and 30.
  • The most common grade ≥3 adverse events (occurring with an incidence of ≥10%) were elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting studies.

Click here for calaspargase pegol-mknl prescribing information.