シアトル・ジェネティクス【SGEN】の掲示板
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“This is one of several brentuximab vedotin regulatory milestones during 2017 towards our goal of expanding its availabilty globally to patients in need. We recently submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for brentuximab vedotin approval in cutaneous T-cell lymphoma based primarily on our phase III ALCANZA clinical trial, and we plan to submit a supplemental BLA to the FDA for brentuximab vedotin in frontline Hodgkin lymphoma based on the positive phase III ECHELON-1 clinical trial. We plan to follow up with submissions to Health Canada for indications in these settings,” Siegall added.
Brentuximab vedotin is currently not approved for use in Cutaneous T-Cell Lymphoma (CTCL) or frontline Hodgkin lymphoma.
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Brentuximab vedotin is an antibody-drug conjugate or ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumor cells.
The drug is used in the treatment of lymphoma, a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.