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  • dinepat203 dinepat203 Jun 25, 2013 12:00 PM Flag

    AVASTIN - Banned by PRAC in Europe Now...

    4.1.3. Bevacizumab – AVASTIN (CAP)
    • Signal of anaphylactic shock
    Regulatory details:
    PRAC Rapporteur: Doris Stenver (DK)
    Background
    Bevacizumab is a monoclonal antibody used in combination with other antineoplastic agents in the treatment of different types of cancer.
    The exposure for Avastin a centrally authorised medicine containing bevacizumab, is estimated to have been more than 1,300,000 patients worldwide in the period from first authorisation in 2004 until 2011.
    During routine signal detection activities, a signal of anaphylactic shock (MedDRA preferred term) was identified by the EMA, based on 88 cases retrieved from EudraVigilance. The Rapporteur confirmed that the signal needed initial analysis and prioritisation by the PRAC.
    Discussion
    The PRAC discussed the information on the cases of anaphylactic shock and noted that in the majority (85%) of the cases, the patients were treated for colon, rectal, colorectal or large intestinal carcinoma. Ten of these cases had no other explanation for the reaction that occurred after or during the infusion of bevacizumab. Severe anaphylactic reactions and cytokine release reactions including fatalities have been already reported in patients treated with other monoclonal antibodies and the product information for Avastin (bevacizumab) was recently updated to communicate the risk of developing infusion and hypersensitivity reactions. The different biological mechanisms underlying infusion reactions remain not fully characterised; however, the PRAC agreed that this new evidence warranted further review.
    Summary of recommendation(s)
    • The MAH for Avastin (bevacizumab) should submit to the EMA, within 30 days, a variation for an update of the product information which reflects the most recent information identified in Eudravigilance.
    • Furthermore the MAH should provide information regarding the status for development of an assay aiming at diagnosing anaphylaxis due to IgE hypersensitivity.

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