Bristol-Myers Squibb has been granted European Union approval for Sprycel in the treatment of adults chronic myeloid leukaemia (CML) or acute lymphoblastic leukaemia (ALL) who have demonstrated resistance or intolerance to prior therapy.
Sprycel (dasatinib) was approved for this indication in the USA in June, providing a new treatment option for patients with CML who cannot get effective treatment using Novartis’ blockbuster drug Glivec/Gleevec (imatinib), which has emerged as the gold standard therapy for the disease.
In a statement, B-MS said that the product is already available in Austria, Germany, France, Finland, Sweden and the UK, and will be rolled out in other EU countries as pricing and reimbursement laws allow.
The European Medicines Agency's (EMEA) approval decision is based on data from five Phase II multicenter studies of the drug in CML and Ph+ ALL patients who were resistant or intolerant to Glivec. The results indicated that the agent demonstrated significant haematological and cytogenetic efficacy, and had brought about durable responses in those treated.
In addition, the drug was shown to have a predictable and manageable profile of side effects, the most common of which were pleural effusion and peripheral oedema, diarrhoea, nausea and vomiting. Myelosuppression was also reported in all of the studies, particularly among patients with more advanced disease.
B-MS maintains that Sprycel is able to inhibit a wider range of mutation subtypes of the Bcr-Abl protein, which is over-expressed in CML, than Glivec. Analysts have suggested it could achieve sales of around $500 million a year, potentially becoming a blockbuster product if its indications are expanded to include first-line treatment of leukaemia or other forms of cancer.
B-MS has said it is also testing the drug in breast, prostate and pancreatic cancers, as well as tumours of the gastrointestinal tract.