Antisoma of the UK is celebrating the news that the US Food and Drug Administration has approved its tablet formulation of fludarabine as a second-line treatment for chronic lymphocytic leukaemia.

The move represents the first product approval for Antisoma and the firm notes that oral fludarabine provides an alternative means to administer the drug that avoids the need for patients to have an intravenous infusion. Until now, the latter formulation was the only one approved in the USA.

The challenge now is to find a partner to sell the treatment for CLL, the most common form of the disease among adults in the western world. Antisoma chief executive Glyn Edwards, said that the FDA approval “puts us in a very good position to conclude a commercialisation deal for the drug”.

He added that “we anticipate a deal that allows us to realise the full value of oral fludarabine while placing the drug with a partner who can make it available as soon as possible as a new treatment option for US patients with CLL.” The firm added that talks are ongoing with “a number of companies that have established oncology marketing operations in the USA” and Antisoma expects to conclude a deal early in 2009.

Oral and intravenous formulations are in use in Europe, Canada and elsewhere, and in France and the UK, the former has been widely adopted, representing 60%-70% of fludarabine prescriptions.