BeOne Medicines Ltd. â Brukinsa EMA EPAR public assessment report (EMEA/H/C/004978, 2021)
BeOne Medicines Ltd. · 2021 · EMA EPAR public assessment report · company profile â
Report summary
This report summarizes the EMA's assessment of Brukinsa (zanubrutinib) for Waldenströmâs macroglobulinaemia (WM). The application, from BeiGene Ireland Ltd, proposes treatment for adult WM patients who have received prior therapy or as first-line for those unsuitable for chemo-immunotherapy. The report details zanubrutinib's chemical properties, manufacturing, and stability as an 80 mg immediate-release capsule. Non-clinical studies highlight its potent, selective, and irreversible BTK inhibition, superior to ibrutinib in some aspects, with low hERG inhibition risk. Preclinical safety identified gastrointestinal, skin, and lymphoid toxicities in animals, and teratogenic effects in rats. Clinically, zanubrutinib shows rapid absorption, dose-proportional exposure with high variability, a 3-4 hour half-life, and significant interactions with CYP3A4 modulators.
Key findings â cited to the page
| Orphan medicinal product designation number | EU/3/19/2167 | Brukinsa · EU · p.6 |
| Orphan medicinal product designation date | 29 May 2019 | Brukinsa · EU · p.6 |
| Positive opinion for marketing authorisation date | 16 September 2021 | Brukinsa · p.8 |
| Capsule strength | 80 mg | Brukinsa · p.11 |
| Marketing Authorisation Application submission date | 28 May 2020 | Brukinsa · EU · p.6 |
| Recommended total daily dose | 320 mg | Brukinsa · p.11 |
| Orphan medicinal product designation withdrawal date | 4 October 2021 | Brukinsa · EU · p.6 |
| Supportive stability data for AS at 30°C / 65% RH | 48 months | · p.14 |
| Stability data duration under accelerated conditions (40°C / 75% RH) | 6 months | · p.14 |
| Number of representative batches of zanubrutinib manufactured | 26 | · p.14 |
| Dose for organ weight alterations in 13-week study in rats | 300 mg/kg/day | · p.38 |
| Stability data duration under long term conditions (30°C / 65% RH) | 24 months | · p.14 |
Source: BeOne Medicines Ltd. â · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only â not investment advice. Explore the Oncology library â