Trial Profile
An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma
Status:
Active, no longer recruiting
Phase of Trial:
Phase II
Latest Information Update: 12 Mar 2024
Price :
$35
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At a glance
- Drugs Zanubrutinib (Primary) ; Obinutuzumab
- Indications B-cell lymphoma; Follicular lymphoma; Non-Hodgkin's lymphoma
- Focus Registrational; Therapeutic Use
- Acronyms ROSEWOOD
- Sponsors BeiGene
- 07 Mar 2024 According to a BeiGene media release, company announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BRUKINSA (zanubrutinib) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), in combination with the anti-CD20 monoclonal antibody obinutuzumab, after two or more lines of systemic therapy.
- 26 Feb 2024 According to a BeiGene media release, company to receive FDA approval in combination with obinutuzumab for the treatment of adult patients with R/R FL who have received at least two prior lines of systemic therapy in March 2024 and NMPA approval in June 2024.
- 07 Feb 2024 According to a BeiGene media release, company announced it received Health Canada authorization for the use of BRUKINSA (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma who have received at least two prior systemic therapies based on positive results from ROSEWOOD trial.