Regulatory Affairs

Shire gets EC nod for lyophilized Oncaspar to treat acute lymphoblastic leukemia

PBR Staff Writer Published 13 December 2017

Shire has secured marketing approval from the European Commission (EC) for new formulation of Oncaspar to treat patients with acute lymphoblastic leukemia (ALL).

The approval has been granted for lyophilized Oncaspar as a component of antineoplastic combination therapy to treat ALL in pediatric patients from birth to 18 years and adult patients.

The EC approval allows the company to market new treatment in 28 member states of the European Union (EU), in addition to Iceland, Liechtenstein and Norway.

In October this year, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended lyophilized Oncaspar to treat ALL.

Through depleting serum L-asparagine levels and later interfering with protein synthesis, Oncaspar will divest lymphoblasts of L-asparagine to kill cells.

According to the company, Asparaginase is a crucial component of the treatment regimen for ALL patients, as it will induce leukemic cell death.

The company is planning to start the marketing of lyophilized Oncaspar from the first half of 2018.

Shire global research and development ad-interim head and SVP Dr Howard Mayer said: “This approval underscores Shire’s commitment to patients with acute lymphoblastic leukemia through continued research and evolution of asparaginase therapy.

“With this lyophilized formulation, we aim to make pegylated asparaginase, part of the pediatric standard therapy in acute lymphoblastic leukemia, available to patients in countries where liquid Oncaspar is not currently offered.

“Additionally, with extended shelf life up to 24 months, treatment centers will have flexibility in inventory management to help ensure continuous treatment supply for patients.”