Irish-headquartered biopharmaceutical company Shire’s lyophilised Oncaspar (pegaspargase) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for patients with acute lymphoblastic leukaemia (ALL).
The CHMP’s positive opinion recommends the marketing authorisation of lyophilised Oncaspar as a component of antineoplastic combination therapy in ALL in paediatric patients from birth to 18 years and in adult patients. ALL is a cancer of the white blood cells.
The freeze-dried formulation of oncaspar works the same way as the liquid formulation, which is currently approved for the same indication in ALL and is part of the paediatric standard therapy in ALL in many European countries.
This formulation rapidly depletes serum L-asparagine levels and interferes with protein synthesis, thereby depriving lymphoblasts of asparaginase and resulting in cell death.
Shire Global Research and Development SVP and ad-interim head Howard B. Mayer said: “Lyophilised oncaspar builds on more than a decade of data and research with liquid oncaspar, and with no change in dosing regimen, it offers a three-times longer shelf life.
“Prolonging shelf life to 24 months for this critically important therapy facilitates management of product inventory by enabling greater flexibility and longer-term planning.
“Once approved, with the extended shelf life of lyophilised oncaspar, we also hope to improve access to the medicine for ALL patients in countries currently not offering liquid oncaspar.”
The positive opinion is based on analytical and nonclinical studies, which demonstrate that the lyophilised formulation of oncaspar is comparable to the liquid formulation.
The new lyophilised formulation demonstrates similar pharmacokinetic (PK) / pharmacodynamics (PD) to liquid oncaspar and offers no change in dosing regimen but a longer shelf life that is three times that of the liquid formation.