FDA Okays Bendamustine (Treanda) for CLL

By Todd Neale
FRAZER, Pa., March 20 -- The FDA has approved bendamustine (Treanda) to treat chronic lymphocytic leukemia, announced Cephalon, U.S. developer of the drug.
Bendamustine, granted orphan drug status, was okayed on the basis of a randomized, international, multicenter, open-label phase III study comparing the drug to chlorambucil, already approved to treat the disease.
Of 301 chronic lymphocytic leukemia patients, 59% of those given bendamustine responded to treatment compared with just 26% of those who received chlorambucil (P<0.0001).
Bendamustine patients were also more likely to show a complete response to treatment than chlorambucil patients (8% versus less than 1%).
And progression-free survival was three times longer in those who received bendamustine (18 months versus six months, P<0.0001).
The most common adverse events in the bendamustine group were neutropenia (28%), thrombocytopenia (23%), anemia (19%), leukopenia (18%), pyrexia (24%), nausea (20%), and vomiting (16%).
Bendamustine causes cell death via several pathways, although the exact mechanism is unknown.
Recommended dosage is 100 mg/m2 infused intravenously on days one and two of a 28-day cycle for up to six cycles.