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Bendamustine HCl

Description of Bendamustine: Bendamustine hydrochloride is the hydrochloride salt of bendamustine, a bifunctional mechlorethamine derivative with alkylator and antimetabolite activities. Bendamustine possesses three active moieties: an alkylating group; a benzimidazole ring, which may act as a purine analogue; and a butyric acid side chain. Although its exact mechanism of action is unknown, this agent appears to act primarily as an alkylator. Bendamustine metabolites alkylate and crosslink macromolecules, resulting in DNA, RNA and protein synthesis inhibition, and, subsequently, apoptosis. Bendamustine may differ from other alkylators in that it may be more potent in activating p53-dependent stress pathways and inducing apoptosis; it may induce mitotic catastrophe; and it may activate a base excision DNA repair pathway rather than an alkyltransferase DNA repair mechanism. Accordingly, this agent may be more efficacious and less susceptible to drug resistance than other alkylators. Bendamstine was approved in USA in March 2008. Check for active clinical trials or closed clinical trials using this agent. (NCI Thesaurus).

Current developer:   Cephalon, Inc

According to http://en.wikipedia.org/wiki/Bendamustine, bendamustine was first synthesized in 1963 by Ozegowski and Krebs in East Germany (the former German Democratic Republic). It is a white, water soluble microcrystalline powder with amphoteric properties. Until 1990 it was available only in East Germany. East German investigators found that it was useful for treating chronic lymphocytic leukemia, Hodgkin’s disease, non-Hodgkin’s lymphoma, multiple myeloma and lung cancer.

Bendamustine received its first marketing approval in Germany, which is marketed under the tradename Ribomustin, by Astellas Pharma GmbH's licensee, Mundipharma International Corporation Limited, which it is indicated as a single-agent or in combination with other anti-cancer agents for indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCl in Japan and selected Asia Pacific Rim countries.

In March 2008, Cephalon received approval from the United States Food and Drug Administration to market bendamustine in the US, where it is sold under the tradename Treanda, for treatment of CLL.  In October 2008, the FDA granted further approval to market Treanda for the treatment of indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

 1: Elefante A, Czuczman MS. Bendamustine for the treatment of indolent non-Hodgkin's lymphoma and chronic lymphocytic leukemia. Am J Health Syst Pharm. 2010 May 1;67(9):713-23. PubMed PMID: 20410545.

2: Tageja N, Nagi J. Bendamustine: something old, something new. Cancer Chemother Pharmacol. 2010 Apr 8. [Epub ahead of print] PubMed PMID: 20376452.

3: Cheson BD, Wendtner CM, Pieper A, Dreyling M, Friedberg J, Hoelzer D, Moreau P, Gribben J, Knop S, Montillo M, Rummel M. Optimal use of bendamustine in chronic lymphocytic leukemia, non-Hodgkin lymphomas, and multiple myeloma: treatment recommendations from an international consensus panel. Clin Lymphoma Myeloma Leuk. 2010 Feb;10(1):21-7. PubMed PMID: 20223726.

4: Michael M, Bruns I, Bölke E, Zohren F, Czibere A, Safaian NN, Neumann F, Haas R, Kobbe G, Fenk R. Bendamustine in patients with relapsed or refractory multiple myeloma. Eur J Med Res. 2010 Jan 29;15(1):13-9. PubMed PMID: 20159666.

5: Owen JS, Melhem M, Passarell JA, D'Andrea D, Darwish M, Kahl B. Bendamustine pharmacokinetic profile and exposure-response relationships in patients with indolent non-Hodgkin's lymphoma. Cancer Chemother Pharmacol. 2010 Feb 6. [Epub ahead of print] PubMed PMID: 20140617.

6: Dennie TW, Kolesar JM. Bendamustine for the treatment of chronic lymphocytic leukemia and rituximab-refractory, indolent B-cell non-Hodgkin lymphoma. Clin Ther. 2009;31 Pt 2:2290-311. Review. PubMed PMID: 20110042.

7: Cheson BD, Kroll ML. Bendamustine induced neurotoxicity. Clin Adv Hematol Oncol. 2009 Nov;7(11):743-6. PubMed PMID: 20075832.

8: Gandhi V, Burger JA. Bendamustine in B-Cell Malignancies: The New 46-Year-Old Kid on the Block. Clin Cancer Res. 2009 Dec 15;15(24):7456-7461. Epub . PubMed PMID: 19996200; PubMed Central PMCID: PMC2795094.

9: Kahl BS, Bartlett NL, Leonard JP, Chen L, Ganjoo K, Williams ME, Czuczman MS, Robinson KS, Joyce R, van der Jagt RH, Cheson BD. Bendamustine is effective therapy in patients with rituximab-refractory, indolent B-cell non-Hodgkin lymphoma: results from a Multicenter Study. Cancer. 2010 Jan 1;116(1):106-14. PubMed PMID: 19890959.

10: Moosmann P, Heizmann M, Kotrubczik N, Wernli M, Bargetzi M. Weekly treatment with a combination of bortezomib and bendamustine in relapsed or refractory indolent non-Hodgkin lymphoma. Leuk Lymphoma. 2010 Jan;51(1):149-52. PubMed PMID: 19860608.

11: Glode AE, Jarkowski A. Bendamustine: a new treatment option for chronic lymphocytic leukemia. Pharmacotherapy. 2009 Nov;29(11):1375-84. Review. PubMed PMID: 19857152.

12: Friedberg JW. Bendamustine in chronic lymphocytic leukemia: the future is combination therapy. Leuk Lymphoma. 2009 Sep;50(9):1399-400. PubMed PMID: 19811324.

13: Glance LE, Cumpston A, Kanate A, Remick SC. Bendamustine-associated hemolytic anemia. Ann Pharmacother. 2009 Nov;43(11):1903-6. Epub 2009 Oct 6. PubMed PMID: 19809007.

14: Steinbild S, Frost A, Häring B, Unger C, Mross K. Phase II STUdy with 3rd- or 4th-line bendamustine (flat dose) therapy in patients with metastatic breast cancer. Onkologie. 2009 Sep;32(8-9):488-92. Epub 2009 Jul 23. PubMed PMID: 19745592.

15: von Minckwitz G, Linder M, Loibl S. The reawakening of bendamustine - also in breast cancer? Onkologie. 2009 Sep;32(8-9):462-3. Epub 2009 Aug 12. PubMed PMID: 19745588.

16: Knauf WU, Lissichkov T, Aldaoud A, Liberati A, Loscertales J, Herbrecht R, Juliusson G, Postner G, Gercheva L, Goranov S, Becker M, Fricke HJ, Huguet F, Del Giudice I, Klein P, Tremmel L, Merkle K, Montillo M. Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia. J Clin Oncol. 2009 Sep 10;27(26):4378-84. Epub 2009 Aug 3. PubMed PMID: 19652068.

17: Eichbaum M, Bischofs E, Nehls K, Schneeweiss A, Sohn C. Bendamustine hydrochloride - a renaissance of alkylating strategies in anticancer medicine. Drugs Today (Barc). 2009 Jun;45(6):431-44. PubMed PMID: 19649333.

18: Leong H, Bonk ME. Bendamustine (Treanda) For Chronic Lymphocytic Leukemia: A Brief Overview. P T. 2009 Feb;34(2):73-76. PubMed PMID: 19561839; PubMed Central PMCID: PMC2697069.

19: Masiello D, Tulpule A. Bendamustine therapy in chronic lymphocytic leukemia. Expert Opin Pharmacother. 2009 Jul;10(10):1687-98. Review. PubMed PMID: 19527193.

20: Sanchez-Gonzalez B, Garcia M, Serrano S, Besses C, Salar A. Bendamustine-containing immunochemotherapy is active in transformed follicular lymphoma with overexpression of p53. Leuk Lymphoma. 2009 Mar;50(3):455-6. PubMed PMID: 19263299.