Calaspargase pegol-mknl (Asparlas®) FDA approved in paediatric and young adult acute lymphoblastic leukaemia (ALL) patients

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By: scienterrific | Last updated: 27 December 2018 | In: US FDA Onc\Haem Approvals, Haematology, Oncology, Paediatric

Article Keywords

pegaspargase, Servier, ALL, FDA, paediatric, leukaemia, acute lymphoblastic leukaemia, Asparlas, B-cell lineage ALL, calaspargase pegol-mknl

On 20 December 2018, the FDA approved the asparagine specific enzyme calaspargase pegol-mknl (Asparlas®, Servier) as a component of multi-agent chemotherapeutic regimens for the treatment of paediatric and young adult patients aged 1 month to 21 years with acute lymphoblastic leukaemia (ALL).

Approval

The approval by the FDA was based on the longer interval between doses when using Asparlas® when compared to other available pegaspargase products. Asparlas® achieved and maintained nadir serum asparaginase activity above 0.1 U/mL at a dose of 2500 U/m² intravenously every 3 weeks (q3wk). A study in 124 patients with B-cell lineage ALL investigated the pharmacokinetics when combined with multiagent chemotherapy.

Safety

Common Grade ≥3 adverse reactions in ≥10% of patients included elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting studies. Randomised data showed that the safety of calaspargase pegol-mknl q3wk was comparable to that of pegaspargase q2wk.

Full prescribing information Asparlas®.

Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).

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