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Bendamustine - Astellas Pharma GmbH

Drug Profile

Bendamustine - Astellas Pharma GmbH

Alternative Names: BENDA; Bendam; Bendamus; Bendamustine HCl; Bendamustine hydrochloride; Bentaman; Cytostasan; Endexin; Esevaril; Innomustine; Levact; Ribomustin; Ribomustine; Ribovact; SDX-105; SyB C-0501; SyB L 1701; SyB L 1702; SyB L-0501; SyB L-0501RI; SyB L-1701 [RTD]; SyB L-1702 [RI]; Symbenda; Treakisym; Treanda

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator Jenapharm
  • Developer Astellas Pharma GmbH; Cantonal Hospital of St Gallen; Eisai Co Ltd; Emory University; Foundation GIMEMA; Genentech; GlaxoSmithKline KK; INNOPHARMAX; Istituto Clinico Humanitas; Janssen-Cilag; Keio University; Memorial Sloan-Kettering Cancer Center; Mundipharma International; Northside Hospital; PETHEMA Foundation; St. Jude Childrens Research Hospital; SymBio Pharmaceuticals; Teva Pharmaceutical Industries; University of Gottingen; University of Texas M. D. Anderson Cancer Center
  • Class Antineoplastics; Benzimidazoles; Butyric acids; Nitrogen mustard compounds; Nitrosourea compounds; Small molecules
  • Mechanism of Action Alkylating agents; Antimetabolites; DNA cross linking agents
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Non-Hodgkin's lymphoma; Chronic lymphocytic leukaemia; Mantle-cell lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Breast cancer; Cancer; Chronic lymphocytic leukaemia; Hodgkin's disease; Mantle-cell lymphoma; Multiple myeloma; Non-Hodgkin's lymphoma
  • Registered Diffuse large B cell lymphoma
  • Phase II Amyloid light-chain amyloidosis; B-cell lymphoma; HER2 negative breast cancer; Marginal zone B-cell lymphoma
  • Phase I/II Follicular lymphoma
  • No development reported Acute myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma; Solid tumours; Systemic lupus erythematosus
  • Discontinued Chronic myeloid leukaemia; Chronic myelomonocytic leukaemia; Myelodysplastic syndromes

Most Recent Events

  • 10 Dec 2022 Efficacy and safety data from a phase II trial in Mantle-cell lymphoma presented at the 64th American Society of Hematology Annual Meeting and Exposition (ASH-2022)
  • 10 Dec 2022 MundiPharma terminates a phase-I/II clinical trials in Follicular lymphoma (Combination therapy) in United Kingdom, Germany, Netherlands (IV) due to slow enrollment prior to December 2022 (EudraCT2011-000097-56) (NTR3028)
  • 28 Jun 2022 No recent reports of development identified for preclinical development in Systemic-lupus-erythematosus in Japan (PO)
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