Schering AG, Germany announced that the European Union type II variation procedure for Fludara Oral to extend the indication to first-line treatment of patients with B-cell chronic lymphocytic leukemia (B-CLL) has successfully been completed.
The recommendation for approval was based on a European phase II study confirming that newly diagnosed patients with B-CLL treated with Fludara Oral had high and durable response rates which was comparable to what has been achieved with intravenous Fludara in the same indication. Furthermore, a significant number of patients achieved a complete response, which is believed to contribute to a better prognosis.
Fludara Oral is approved in more than 50 countries worldwide as second-line therapy for B-CLL patients who have failed previous treatment with alkylating agents. Fludara is available on the market also as intravenous formulation and besides CLL approved for second-line line treatment of low-grade non-Hodgkin's lymphoma (NHL) in Canada, Switzerland and some other countries, the company release says.
B-CLL is the most prevalent form of adult leukaemia, annually affecting approximately 60,000 people in the United States and 60,000 in Europe. The disease is most commonly diagnosed in people age 50 or older. B-CLL is characterized by the accumulation of functionally immature white blood cells (lymphocytes) in the bone marrow, blood, lymph tissue, and other organs.