Drug Profile


Alternative Names: BMS-354825; Sprycel

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Bristol-Myers Squibb
  • Developer Bristol-Myers Squibb; Dana-Farber Cancer Institute; Massachusetts General Hospital; Otsuka Pharmaceutical; Sarcoma Alliance for Research through Collaboration; University of Texas M. D. Anderson Cancer Center; Weill Cornell Medical College
  • Class Amides; Antineoplastics; Chlorobenzenes; Piperazines; Pyrimidines; Small molecules; Thiazoles
  • Mechanism of Action Bcr-abl tyrosine kinase inhibitors; EphA2 receptor antagonists; Platelet-derived growth factor beta receptor antagonists; Proto oncogene protein c-kit inhibitors; Src-Family kinase inhibitors
  • Orphan Drug Status

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

    Yes - Chronic myeloid leukaemia; Acute lymphoblastic leukaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Acute lymphoblastic leukaemia; Chronic myeloid leukaemia
  • Phase III Prostate cancer
  • Phase II Breast cancer; Cholangiocarcinoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Myeloproliferative disorders; Sarcoma
  • Phase I/II Glioblastoma; Non-Hodgkin's lymphoma
  • Phase I Colorectal cancer; Leukaemia; Mesothelioma; Multiple myeloma; Non-small cell lung cancer
  • No development reported Malignant melanoma
  • Discontinued Pancreatic cancer; Scleroderma

Most Recent Events

  • 10 Jul 2017 Dasatinib receives priority review status for Philadelphia chromosome-positive chronic phase Chronic myeloid leukaemia (In children, In adolescents) in USA
  • 10 Jul 2017 US FDA assigns Prescription Drug User Fee Act (PDUFA) date of 9 November, 2017 for Chronic myeloid leukaemia (In adolescents, In children) in USA (PO, Powder and Tablet)
  • 10 Jul 2017 Preregistration for Chronic myeloid leukaemia (In adolescents, In children) in USA (PO, Powder and Tablet)
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