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An expert panel hosted by
Sequencing immune-based therapies in B-cell malignancies
with Ulric Jäger, Sagar Lonial, and Krina Patel
Saturday, June 15 | 18:00-19:30 CEST
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On 16th August 2017, the U.S. Food and Drug Administration (FDA) accepted the Supplemental Biologics License Application (sBLA) submitted by Seattle Genetics, Inc., for Adcetris® (brentuximab vedotin) in the treatment of patients with Cutaneous T-Cell Lymphoma (CTCL). Furthermore, the FDA has granted Priority Review of this application with a target action date of 16th December 2017.
The sBLA is based on data from the phase III ALCANZA trial (NCT01578499), which compared brentuximab vedotin to methotrexate or bexarotene in relapsed/refractory CD30+ CTCL patients. The results of the trial were published in The Lancet in June of this year, which the Lymphoma Hub reported on; read more here. Also, while at this year’s ICML conference, we interviewed Professor Miles Prince from the Peter MacCallum Cancer Center, Melbourne, Australia, on the ALCANZA trial; watch it here.
Additional data from two investigator-sponsored phase II studies were also included in the sBLA. Currently, Adcetris® is not approved by the FDA or the European Medicines Agency (EMA) for CTCL.
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