|
|
|
|
|
|
TABLE OF CONTENTS
|
March 21, 2008 WASHINGTON (Reuters) - Cephalon Inc has won approval from the U.S. Food and Drug Administration to sell Treanda (bendamustine) to treat patients with chronic lymphocytic leukemia, or CLL, the company said on Thursday. Cephalon submitted a study of 301 previously untreated CLL patients who were randomly assigned to receive Treanda or chlorambucil. Fifty-nine percent of patients responded to Treanda, compared with 26% who were treated with the other drug, Cephalon said. Eight percent of patients given Treanda had a complete remission, compared with less than 1% in the other group. For patients overall, the leukemia got worse after a median of 18 months with Treanda, compared with 6 months for chlorambucil. "Treanda is an effective new option that offers a delay in disease progression," Dr. Bruce Cheson, a Georgetown University oncologist, said in a statement issued by Cephalon. Potential side effects including nausea, vomiting and fever occurred more frequently in Treanda patients. Eighty-nine percent in the Treanda group had at least one event recorded, compared with 79% with the comparison drug. Neutropenia occurred in 28% of Treanda patients compared with 14% in the other group. Treanda also is under FDA review for treating indolent B-cell non-Hodgkin's lymphoma. A decision on that use is expected by Oct. 31. Cephalon expects Treanda to be available for U.S. physicians and patients in April. The product has been designated as an orphan drug for a rare disease, which gives Cephalon exclusive marketing rights for CLL until March 2015, the company said. Cephalon spokeswoman Jenifer Antonacci said the company would not disclose Treanda's price until the drug was launched. Copyright 2008 Reuters. Click for Restrictions.
|
