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Treanda approved for chronic lymphocytic leukemia
Source: (cancerfacts.com)
Thursday, March 27, 2008
ROCKVILLE, MD – Mar. 27, 2008 – FDA has approved Treanda® for chronic lymphocytic leukemia treatment. The approval comes a week after the FDA turned down approval for another chronic lymphocytic leukemia drug Genasense®.
Chronic lymphocytic leukemia (CLL) is a type of blood and bone marrow cancer. It is slow in growing compared to other types of leukemia. The disease has no cure yet, but some patients survive for years with the slow growing cancer. According to American Cancer Society's report, an estimated 15,110 new cases of CLL will be reported during 2008, and 4,390 people will die from the disease.
The approval of Treanda, produced by pharmaceutical company Cephalon, was based on a study of 301 chronic lymphocytic leukemia patients that compared Treanda (bendamustine hydrochloride) to Leukeran (chlorambucil) – the most widespread drug for CLL treatment. Treanda showed significantly more life quality improvement, compared to Leukeran.
Of those taking Treanda 59% showed disease symptoms significantly reduced, compared to 26% those taking chlorambucil (Leukeran®). After receiving the entire session of treatment, 8% of those taking Treanda did not have any symptoms, compared to only 1% those taking Leukeran.
Treanda will be available in April 2008. It is also submitted for FDA review for non-Hodgkin lymphoma treatment. FDA will announce the decision in October 2008.
In the case of Genasense, (oblimersen sodium) the FDA did not reject the drug, but asked for more data confirming the effectiveness from its maker, Genta, Inc.
In a study of 241 patients with relapsed or CLL that failed to respond to other treatment patients were randomly assigned to receive a combination chemotherapy (Flu/Cy) with or without Genasense. Results showed that 17 percent of those treated with Genasense achieved a complete response compared to 7 percent who received the combination chemotherapy without Genasense.
By definition, a complete response represents the complete elimination of all clinical signs of leukemia, combined with the elimination of leukemia-related symptoms. The duration of the complete response was also significantly longer for patients treated with Genasense. The median duration of response had had exceeded the 36 months study duration in the Genasense group, however it was reached at 22 months in the Flu/Cy-only group.
The FDA panel that turned down the approval recommended two alternatives for exploring the effectiveness of Genasense that could provide such confirmatory evidence. One option is to conduct an additional clinical trial. The other option is to collect additional information regarding the clinical course and progression of disease in patients from the previous pivotal trial in order to ascertain whether those data contain sufficient confirmatory evidence. The Company currently plans to pursue both of these options.
SOURCE: Compiled from press materials released by Cephalon and Genta, Inc.
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