A Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of Ibritumomab Tiuxetan Injection (ZEVALIN)
Latest Information Update: 18 Mar 2020
At a glance
- Drugs Ibritumomab tiuxetan (Primary)
- Indications Follicular lymphoma; Non-Hodgkin's lymphoma
- Focus Registrational; Therapeutic Use
- Sponsors CASI Pharmaceuticals
- 16 Mar 2020 According to the CASI Pharmaceuticals media release, company expects this study to be initiated by early 2021.
- 19 Feb 2019 According to a CASI Pharmaceuticals media release, the Company currently is addressing certain requirements provided by the Center for Drug Evaluation (CDE), a part of the NMPA, upon satisfying those requirements, the Company will start the ZEVALIN clinical development program in China.
- 19 Feb 2019 According to a CASI Pharmaceuticals media release, the National Medical Products Administration (NMPA) has approved the Company's Clinical Trial Application (CTA) to allow for a confirmatory clinical trial to evaluate the efficacy and safety of ZEVALIN.The Company previously acquired greater China rights to ZEVALIN from Spectrum and intends to launch ZEVALIN in China as soon as the confirmatory trial is completed and marketing approval is received from the NMPA.