Back in August 2011, Adcetris (brentuximab vedotin) was approved under the FDA’s accelerated approval program to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL). Lymphomas are cancers of the lymphatic system. Adcetris is an antibody-drug conjugate that combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30.
Case studies to be discussed:
Clinical Development of Brentuximab Vedotin: Five Remarkable Years from First Patient Treated to Accelerated Approval
Eric Sievers, M.D., Vice President, Clinical Affairs, Seattle Genetics
Observation of multiple complete remissions among advanced lymphoma patients treated in a phase one setting led Seattle Genetics to pursue paired, single-arm, registrational trials. This presentation will review the overall strategy that led to marketing registration in 2011.
Accelerated Approval of a Targeted Antibody-Drug Conjugate (ADC): Brentuximab Vedotin Case Study
Elaine S. Waller, Pharm.D., M.B.A., Senior Vice President, Regulatory Affairs, Seattle Genetics, Inc.
FDA review of the brentuximab vedotin BLAs was complex due to inclusion of two indications, the ADC technology, and an ODAC environment influenced by recent hearings on accelerated approval of oncology drugs.
Early registration discounts are available until November 18, 2011. To view the entire conference agenda and to register, please visit http://www.TriConference.com/
CHI's Oncology Clinical Trials conference is part of the Molecular Medicine Tri-Conference.
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