A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Safety and Efficacy of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 24 Oct 2018
At a glance
- Drugs Zanubrutinib (Primary)
- Indications Chronic lymphocytic leukaemia
- Focus Registrational; Therapeutic Use
- Sponsors BeiGene
- 24 Oct 2018 According to a BeiGene media release, Updated data with additional follow-up of the patients in the study will be submitted to the NMPA as an additional document of the NDA and are planned to be presented at an upcoming medical conference.
- 24 Oct 2018 An independent review of response data (data cut-off of June 15, 2018) from the study presented in a BeiGene media release.
- 24 Oct 2018 According to a BeiGene media release, the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) for zanubrutinib for the treatment of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The NDA is supported by an extensive clinical, non-clinical and chemistry, manufacturing and control (CMC) data package, including the results from this trial.