Bristol-Myers Squibb’s Sprycel to be reviewed as children’s leukaemia therapy

Bristol-Myers Squibb's drug Sprycel is to be reviewed as a new paediatric treatment for chronic Philadelphia chromosome-positive chronic myelogenous leukaemia (CML).

The European Medicines Agency has validated a grouped Type II variation/extension of application for Sprycel to treat children and adolescents aged one to 18 years, and to include the powder for oral suspension.

This application is supported by data from CA180-226, an ongoing phase II trial studying Sprycel in newly-diagnosed chronic phase CML paediatric patients, and in children who have proven resistant to or intolerant of imatinib.

Validation of the application confirms the submission is complete, meaning the European Medicines Agency can now commence its centralised review process.

Murdo Gordon, executive vice-president and chief commercial officer of Bristol-Myers Squibb, said: "Treatment options for paediatric patients with chronic phase CML, along with formulations that support the unique demands of children with cancer, continue to be unmet needs."

Sprycel is approved and marketed worldwide for the treatment of CML and acute lymphoblastic leukaemia in more than 60 countries.

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