Date: 2012-10-25
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Kyowa Hakko Kirin Pharma (Japan)
Product: mogamulizumab (KW-0761)
Action
mechanism: monoclonal antibody. Mogamulizumab is a novel, humanized mAb directed against CC chemokine receptor 4 (CCR4). Engineered by Kyowa Hakko Kirin's unique POTELLIGENT® Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity. Mogamulizumab was launched in Japan in May 2012 for the treatment of patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma (ATL). The drug was approved for indication expansion and was granted marketing authorization in Japan for the treatment of patients with relapsed or refractory CCR4-positive, peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) in March 2014, and with chemotherapy-native CCR4-positive ATL in December 2014. Clinical trials with mogamulizumab are ongoing in the US, EU and other countries.
Disease: cutaneous T-cell lymphoma
Therapeutic area: Cancer - Oncology
Country: Australia, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, Switzerland, UK, USA
Trial
details: The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory cutaneous T-cell lymphoma. (NCT01728805)
Latest
news: * On October 25, 2012, a Phase 3 trial sponsored by Kyowa Hakko Kirin Pharma was published on the NIH website ClinicalTrials.gov for mogamulizumab (KW-0761) and is currently ongoing.
