A confirmatory trial of Ibritumomab-tiuxetan
Phase of Trial: Phase III
Latest Information Update: 15 Sep 2017
At a glance
- Drugs Ibritumomab tiuxetan (Primary)
- Indications Non-Hodgkin's lymphoma
- Focus Registrational; Therapeutic Use
- 15 Sep 2017 New trial record
- 07 Sep 2017 According to a CASI Pharmaceuticals media release, the confirmatory trial is required as part of the registration process for the import drug registration.
- 07 Sep 2017 According to a CASI Pharmaceuticals media release, the CFDA review of the import drug clinical trial application (CTA) for Ibritumomab-tiuxetan is in process. The ZEVALIN antibody kit and the radioactive Yttrium-90 component of the clinical trial application require separate submissions to the CFDA, which the first part is currently under review and the latter part is in the submission process. The company expects to initiate the confirmatory trial within six months after CTA approval.