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European Commission Approves Label Variation for ADCETRIS (Brentuximab Vedotin)

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Additional Relevant Details Takeda announced that the European Commission (EC) has approved a Type II variation for ADCETRIS (brentuximab vedotin) to include data on the retreatment of adult patients with relapsed or refractory (R/R) Hodgkin lymphoma or R/R systemic anaplastic large cell lymphoma (sALCL) who previously responded to ADCETRIS and who later relapse. The decision from the EC follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in October 2015.
http://www.takeda.co...
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Catalyst Date
Occurred on:
Jan 22, 2016
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Related Keywords Ec, Approval, Label Variation, Adcetris, Brentuximab Vedotin