Shire’s lyophilised Oncaspar recommended for EU approval in leukaemia

Shire's cancer therapy Oncaspar has been recommended for EU regulatory approval in the treatment of acute lymphoblastic leukaemia (ALL).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of lyophilised Oncaspar as a component of antineoplastic combination therapy for ALL in paediatric and adult patients.

This freeze-dried formulation of Oncaspar works the same way as the liquid formulation, rapidly depleting serum L-asparagine levels and interfering with protein synthesis to cause the death of cancer cells.

However, the lyophilised version offers a three times longer shelf life, meaning it can be stored for 24 months, enabling greater flexibility and longer-term planning.

Dr Howard Mayer, senior vice-president and interim head of global research and development at Shire, said: "Once approved, with the extended shelf life of lyophilized Oncaspar, we also hope to improve access to the medicine for ALL patients in countries currently not offering liquid Oncaspar."

The liquid form of Oncaspar is currently approved for the same indication in ALL and is part of the paediatric standard therapy in ALL in many European countries.

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