Bristol-Myers Squibb CML drug approved by EC

Bristol-Myers Squibb has announced that the European Commission has approved its Sprycel (dasatinib) product for the treatment of patients with accelerated or blast phase chronic myeloid leukaemia (CML) who have shown resistance or intolerance to other types of treatment.

The commission has granted orphan drug status to the compound, which is indicated for the treatment of Philadelphia chromosome positive acute lymphoblastic leukaemia and lymphoid blast CML, in patients exhibiting intolerance or resistance to previous therapy.

A European study revealed resistance to imatinib mesylate could occur in a quarter of patients with chronic phase CML, rising to 41 per cent in accelerated phase and 92 per cent in blast crisis patients.

Beatrice Cazala, president, Europe, Middle East and Africa for Bristol-Myers Squibb, said: “With the approval of Sprycel in Europe, these patients now have an effective therapeutic option that can overcome treatment resistance and intolerance in certain cases.”

In tests reviewed by the European Medicines Agency for the efficacy and tolerance of Sprycel, the compound exhibited predictable and manageable side effects. The drug is currently available in the UK, in addition to Sweden, Finland, France, Germany and Austria.

In June, the drug received Food and Drug Administration approval for the treatment of patients all phases of CML.