Antisoma's CLL tablet approved by US FDA

UK drugmaker Antisoma says that the US Food and Drug Administration has approved its tablet formulation of fludarabine phosphate as a  second-line treatment for chronic lymphocytic leukemia.

According to the London-headquartered firm, the agent provides an  alternative means to administer fludarabine that avoids the need for  patients to have an intravenous infusion. Antisoma plans to make the  drug available to US patients through a commercialization deal. Talks  are ongoing with a number of companies that have established US oncology  marketing operations and Antisoma expects to conclude a deal early next  year.

CLL is the most common leukemia among adults in the western world.  Fludarabine is an established drug in the treatment of CLL worldwide.  Oral and intravenous formulations are in use in Europe, Canada and  elsewhere but, until now, only the intravenous formulation has been  available in the USA. In France and the UK, the oral formulation has  been widely adopted, representing some 60% to 70% of fludarabine  prescriptions.