FDA approves longer-acting calaspargase pegol-mknl for ALL
- FLASCO
- December 27, 2018
- News
On
December 20, 2018, the Food and Drug Administration approved calaspargase
pegol-mknl (ASPARLAS™, Servier Pharmaceuticals LLC), an asparagine specific
enzyme, as a component of a multi-agent chemotherapeutic regimen for acute
lymphoblastic leukemia (ALL) in pediatric and young adult patients age
1 month to 21 years. 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.
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.
View full prescribing information for
ASPARLAS.
Calaspargase pegol-mknl received FDA orphan product designation.
Healthcare professionals should report all serious adverse events suspected to
be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by
calling 1-800-FDA-1088.
Follow the Oncology Center of Excellence on Twitter @FDAOncology.
Check out recent approvals at the OCE’s podcast, Drug Information Soundcast in Clinical
Oncology (D.I.S.C.O.).