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Celgene Corp. (CELG) Message Board

  • rob_cos rob_cos Aug 14, 2013 10:30 AM Flag

    Pomalidomide licensed for use in the UK for the treatment of adults with relapsed/refractory multiple myeloma

    Pomalidomide Celgene® - (pomalidomide) licensed for use in the UK for the treatment of adults with relapsed/refractory multiple myeloma

    Main Category: Lymphoma / Leukemia / Myeloma
    Also Included In: Regulatory Affairs / Drug Approvals
    Article Date: 12 Aug 2013 - 2:00 PDT

    Celgene has confirmed that Pomalidomide Celgene® - (pomalidomide), a new oral blood cancer therapy, has been granted Marketing Authorisation by the European Medicines Agency and is now available in the UK and Ireland. Pomalidomide is for use in combination with dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma (rrMM) who have received at least two prior therapies including both lenalidomide and bortezomib, and have demonstrated disease progression while on their last therapy.

    The authorisation is based on compelling results from the pivotal Phase III MM-003 study, which demonstrated significant advantages for pomalidomide in progression-free survival and overall survival when compared to high dose dexamethasone alone.[1],[2]

    "Today's decision represents a significant milestone for people with multiple myeloma," said Professor Steve Schey, lead investigator for the MM-003 study and Consultant Haematologist at King's College Hospital, London. "These patients have exhausted multiple therapies, including current standards of care. The introduction of pomalidomide gives these patients another option and can potentially help extend remissions in this incurable disease."

    Multiple myeloma is the second most common blood cancer[3] and affects an estimated 9,900 people in the UK and Ireland.[4] The disease causes plasma cells to replicate uncontrollably and accumulate in the bone marrow, disrupting the production of normal blood cells. Nearly all individuals diagnosed with multiple myeloma will eventually relapse and require treatment with an alternative therapy.[5]
    (continued in reply)

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    • "Today's decision represents a significant milestone for people with multiple myeloma," said Professor Steve Schey, lead investigator for the MM-003 study and Consultant Haematologist at King's College Hospital, London. "These patients have exhausted multiple therapies, including current standards of care. The introduction of pomalidomide gives these patients another option and can potentially help extend remissions in this incurable disease."

      Multiple myeloma is the second most common blood cancer[3] and affects an estimated 9,900 people in the UK and Ireland.[4] The disease causes plasma cells to replicate uncontrollably and accumulate in the bone marrow, disrupting the production of normal blood cells. Nearly all individuals diagnosed with multiple myeloma will eventually relapse and require treatment with an alternative therapy.[5] For this reason, it is crucial that new and effective options continue to be made available to them to enable continued disease control.[2]

      The European Medicines Agency's decision was based on the results from the MM-003 study, a Phase III, multi-centre, randomised (2:1), open-label study in 455 patients.[7] The results demonstrated significantly improved median progression-free survival of 3.6 months; p

 
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