Cephalon's Treanda gets FDA approval

The Food and Drug Administration has given clearance to Cephalon’s Treanda, generically known as Bendamustine, for the treatment of chronic lymphocytic leukemia.

Chronic lymphocytic leukemia is a slowly progressing disease in which there is an over-production of white blood cells that do not mature into infection-fighting cells of the immune system. These cells crowd out mature white blood cells in the blood and bone marrow.

The trial conducted on 300 patients compared Treanda, to another chemotherapy drug, Chlorambucil. It was found that the patients who took Treanda saw fewer signs of cancer development. Even in the cases where there was formation of the cancer, the progression was slower.

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

The median progression-free-survival time for the Bendamustine group was 18 months, compared to 6 months for the Chlorambucil group.

The Bendamustine group however, reported more severe side effects resulting in a need for blood transfusions. The most common side effects were Neutropenia, fever, Thrombocytopenia, Nausea, Anemia, Leucopenia, and Vomiting.

The American Cancer Society estimates, that more than 15,000 new cases of the disease will be diagnosed in the U.S. this year. Thus, this drug is expected to be of real use in the coming times.

Cephalon, which already has acute Promyelocytic Leukemia drug Trisenox in the market, had total sales of $1.7 billion for 2007. JP Morgan analyst Adam Greene projected $20 million in Treanda sales this year and about $320 million by 2012.

Treanda has been approved under the orphan drug program, thus it gets exclusive marketing rights until 2015. This program awards market exclusivity to companies that develop drugs for rare diseases.

Treanda will be available to physicians and patients by April 2008 but, its price has not yet been disclosed.

FDA is also reviewing the drug for treating a different type of blood cancer, Indolent B-cell non-Hodgkin's lymphoma. A final decision on this issue is expected to be taken by October 31.

Cephalon shares have gained $1.56, or 2.5 percent, to close at $64.17 on NASDAQ