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Thursday, 18 July 2013
Summary Basis of Decision for Adcetris
Health Canada has issued a Notice of Compliance under the Notice of Compliance with Conditions Guidance to Seattle Genetics, Inc. for the drug product Adcetris. Based on Health Canada's review, the benefit/risk profile of Adcetris is favourable for: 1. The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates; 2. The treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one multi-agent chemotherapy regimen. Read more here.
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