Treanda for CLL: approved!!

[Guest guest]

This is very, very big news. Also: approval for CLL opens the door for

off-label use, for all the lymphomas, based on very good supporting data. ~

Karl

Treanda Treats Rare Cancer

Chemotherapy drug approved for chronic lymphocytic leukemia

Posted 3/20/08

THURSDAY, March 20 (HealthDay News) -- The Cephalon drug Treanda

(bendamustine hydrochloride) has been approved by the U.S. Food and Drug

Administration to treat chronic lymphocytic leukemia, a rare cancer that

affects the blood and bone marrow.

CLL is expected to strike some 15,000 people in the United States this year,

according to American Cancer Society estimates provided by the drugmaker.

In a trial of 301 patients that compared Treanda to an already approved

chemotherapy drug, Treanda recipients had better response rates and longer

progression-free survival, Cephalon said in a statement.

Treanda, expected to hit the U.S. market in April, works by damaging the DNA

in cancer cells, causing these cells to die. Cephalon said the treatment was

granted orphan drug status by the FDA, which offers companies exclusive

marketing rights in return for drugs developed for rare diseases.