Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study.
Phase of Trial: Phase II
Latest Information Update: 22 Jan 2016
At a glance
- Drugs Brentuximab vedotin (Primary)
- Indications Anaplastic large cell lymphoma; Diffuse large B cell lymphoma; Haematological malignancies; Hodgkin's disease; Non-Hodgkin's lymphoma
- Focus Adverse reactions; Registrational; Therapeutic Use
- 22 Jan 2016 According to Takeda Pharmaceutical media release, European Commission 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). EC decision followed the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in October 2015.
- 14 May 2013 Preliminary data were previously reported at the 2011 American Society of Hematology (ASH) Annual Meeting and at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting, according to Seattle Genetics.
- 14 May 2013 The US FDA accepted for filing a supplement to the Biologics License Application supporting the use of brentuximab vedotin for retreatment and extended duration based on the results of this study, according to a Seattle Genetics media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History