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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: 25 Sep 2019

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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
  • Phase III Diffuse large B cell lymphoma
  • Phase II Amyloid light-chain amyloidosis; B-cell lymphoma; Marginal zone B-cell lymphoma
  • Phase I Solid tumours
  • Preclinical Systemic lupus erythematosus
  • No development reported Acute myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma
  • Discontinued Chronic myeloid leukaemia; Chronic myelomonocytic leukaemia; Myelodysplastic syndromes

Most Recent Events

  • 18 Sep 2019 SymBio plans to file an NDA application for relapsed/refractory Diffuse large B-cell lymphoma (Second line therapy or greater) in the second quarter of 2020
  • 07 Aug 2019 Licence agreement of bendamustine between SymBio and Eisai in Japan will expire by December 2020
  • 07 Aug 2019 SymBio has patent protection for bendamustine liquid formulations in Japan
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