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Home Industry News Shire’s Oncaspar receives EU approval in new leukaemia indication

Shire’s Oncaspar receives EU approval in new leukaemia indication

13th December 2017

Shire has received European regulatory approval for a new formulation of Oncaspar indicated for the treatment of acute lymphoblastic leukaemia (ALL).

The European Commission has approved lyophilised Oncaspar as a component of antineoplastic combination therapy in ALL in paediatric and adult patients, following a recommendation from the Committee for Medicinal Products for Human Use of the European Medicines Agency in October.

This lyophilised formulation offers the same dosing regimen as liquid Oncaspar, but with a shelf life that is three times longer than the liquid formulation, meaning supply management is made much easier.

Oncaspar works by depleting serum L-asparagine levels, thereby interfering with protein synthesis and depriving lymphoblasts of L-asparagine, resulting in cell death.

Howard Mayer, senior vice-president and interim head of global research and development at Shire, said: "This approval underscores Shire's commitment to patients with acute lymphoblastic leukaemia through continued research and evolution of asparaginase therapy."

Shire expects this new lyophilised version of Oncaspar to be made available in European markets beginning in the first half of 2018.

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