Bristol-Myers Squibb gets priority review for dasatinib

Bristol-Myers Squibb (BMS) has obtained a priority review of investigational leukaemia drug dasatinib in the US.

In a statement the company said that the new drug application (NDA) for the treatment will be reviewed by the Food and Drug Administration (FDA) within six months from the original submission in December.

As a result, BMS may be able to market dasatinib by June 28th 2006, subject to FDA approval. The firm requested indications to treat chronic myelogenous leukaemia and chromosome-positive acute lymphoblastic leukaemia. Dasatinib would be used with adults who have not previously responded to treatment.

Clinical trials for the drug have been successful. The UT Southwestern Medical Center in Dallas said that 75 per cent of patients treated with the drug responded to the treatment after a month, while a third were reported as having no signs of the chromosomes which characterise the cancer, the Dallas Star-Telegram reported.

In other news, BMS said that phase III clinical trials of Hepatitis B treatment Baraclude demonstrated benefits over Lamivudine.

Researchers discovered that the drug reduced virus DNA to “undetectable levels,” while improving liver histology.

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