China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has received two new indication recommendations in the EU and the United Kingdom for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The approvals expand the therapeutic applications of this innovative treatment, further solidifying its position in the global oncology market.
EU Recommendation for Marginal Zone Lymphoma
The EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending an additional indication approval for Brukinsa in marginal zone lymphoma (MZL) patients who have received at least one prior anti-CD20-based therapy. This recommendation is in addition to its existing approval for Waldenström’s macroglobulinemia (WM).
The marketing recommendation is based on the positive results of the MAGNOLIA study (NCT03846427), an open, multi-center, single-arm Phase II study assessing Brukinsa in 66 patients with relapsed or refractory (R/R) MZL who have received at least one prior anti-CD20 therapy. In this trial, the overall response rate (ORR) was 68% (95% CI: 55.6, 79.1), with 26% achieving a complete response (CR) and 42% achieving a partial response (PR). Subjects had a median time to response of 2.8 months (range: 1.7-11.1 months). The ORRs for extranodal, nodal, splenic, and unknown marginal zone lymphoma subtypes were 64%, 76%, 67%, 67%, and 50%, respectively.
UK Recommendation for Waldenström’s Macroglobulinemia
One day later, England’s health technology assessment institute, the National Institute for Health and Care Excellence (NICE), issued a final appraisal document (FAD) recommending Brukinsa as a treatment for WM in adults who have had at least one prior treatment, provided that bendamustine plus rituximab is also suitable.
This decision from NICE marks Brukinsa as the first and only treatment for WM recommended for routine use in England and Wales. The NICE Committee acknowledged the high unmet need for an effective and well-tolerated treatment for WM, where current chemoimmunotherapy options can cause severe adverse reactions and require frequent hospital visits. The NICE recommendation states that Brukinsa is considered cost-effective at a threshold of GBP 20,000-30,000 ($22,894-34,341) per quality-adjusted life year (QALY).
Drug Overview and Global Development
Brukinsa was discovered in-house by BeiGene and is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Designed to deliver targeted and sustained inhibition of the BTK protein, Brukinsa has demonstrated superior pharmacokinetics compared to other licensed BTK inhibitors, effectively inhibiting the proliferation of malignant B cells in disease-relevant tissues.
Market Presence and Future Outlook
Over 40 market filings have been made globally for Brukinsa, which has obtained market approvals in the US, China, the European Union, Great Britain, Canada, Australia, and additional international markets. Additionally, 35 clinical studies in 28 markets with 4,500 people enrolled are underway. These approvals and ongoing studies highlight BeiGene’s commitment to advancing innovative treatments for B-cell malignancies, addressing significant unmet needs in oncology.-Fineline Info & Tech
