Cephalon wins U.S. approval for leukemia drug

By Lisa Richwine

WASHINGTON (Reuters) - Cephalon Inc won U.S. approval to sell a chemotherapy drug to treat patients with a slow-growing type of leukemia, the company said on Thursday.

The Food and Drug Administration cleared the injectable drug, called Treanda, after a study showed it helped more patients than a common treatment for chronic lymphocytic leukemia, or CLL.

CLL most often hits older adults with an average age of 70 and is more common in men than women. About 15,000 new cases of CLL will be diagnosed in the United States in 2008, according to American Cancer Society estimates.

Cephalon, known for its sleep drug Provigil, is counting on Treanda to give it a bigger presence in the cancer market. Industry analysts project Treanda's eventual peak annual sales could reach between $300 million and $500 million. It also is under FDA review for a type of non-Hodgkin's lymphoma.

Cephalon's total 2007 sales were $1.7 billion.

For Treanda, the company submitted a study of 301 previously untreated CLL patients who were randomly assigned to receive the Cephalon drug or another chemotherapy treatment called chlorambucil.

Fifty-nine percent of patients responded to Treanda, compared with 26 percent who were treated with the other drug, Cephalon said.

Eight percent of patients given Treanda had a complete remission of their leukemia, compared with less than 1 percent in the other group.