B-MS gets more good news from FDA over Sprycel

Bristol-Myers Squibb has been boosted by the news that US regulators have given their backing to a lower recommended starting dose for the firm’s leukaemia drug Sprycel.

The move is part of the US Food and Drug Administration’s approval for new labelling for Sprycel (dasatinib) to include a starting dose of 100mg from 70mg twice a day for patients with chronic myeloid leukaemia who have proved resistant or intolerant to prior therapy with Novartis’ blockbuster Gleevec (imatinib). The approval is based on a Phase III trial of Spycel 100mg once-daily dose which was associated with a lower frequency of severe myelosuppression and fluid retention and the updated label also include safety data from 2,182 patients who have taken the drug.

Claude Nicaise, B-MS’ vice president of global development for the drug, said the company is “fully committed to further exploring and understanding the appropriate use of Sprycel through a robust clinical development programme." Third-quarter sales of the drug, launched in June 2006, rose to $46 million from $11 million in the corresponding period last year and further development on the compound is designed to push that figure up much higher.

Foe example, at the American Society of Clinical Oncology meeting in Chicago in June, B-MS presented data from a Phase II trial of Sprycel which suggest that the compound may be effective in the first-line treatment of chronic myelogenous leukaemia, though it is far too early to say whether its benefit is greater than Gleevec.