Weekly Digest - 11-17 Jul 2023
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - 11-17 Jul 2023
12 Jul 2023: BRUKINSA (zanubrutinib) / Obinutuzumab / R/R Follicular Lymphoma / BeiGene: The US FDA accepted the sNDA for review
- BeiGene seeks FDA approval for BRUKINSA in combination with Obinutuzumab for patients with relapsed refractory Follicular Lymphoma after 2 prior lines of therapy following Phase 2 results from the ROSEWOOD study
- If approved, BRUKINSA will be the first BTK inhibitor to be approved for the treatment of follicular lymphoma; the PDUFA action date is in Q1’24
- ROSEWOOD study included pre-treated R/R non-Hodgkin FL patients
- Efficacy: Zanubrutinib + Obinutuzumab (n= 145) vs Obinutuzumab (n= 72); median follow-up of 12.5 months
- ORR: 68.3% vs 45.8%
- DOR: 69.3%
- Safety:
- Safety consistent with previous studies
- Most common TRAEs: Diarrhea (18.2% vs 16.9%), fatigue (15.4% vs 14.1%), and pyrexia (13.3% vs 19.7%)
- Longer-term data included in the sNDA showed efficacy benefit for Zanubrutinib + Obinutuzumab persisted at a median follow-up of 20.2 months
- ORR: 69.0% vs 45.8%
- Reduced the risk of disease progression or death by 50% (HR 0.50; 95% CI 0.33-0.75)
