Summary
BeOne Medicines Ltd. (ONC), also known as BeiGene, Ltd., reported significant regulatory developments in Europe on September 19th and 20th, 2022. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval for BRUKINSA® (zanubrutinib) in the treatment of adult patients with marginal zone lymphoma (MZL) who have undergone at least one prior anti-CD20 therapy. Furthermore, the National Institute for Health and Care Excellence (NICE) in England issued a final appraisal document recommending BRUKINSA® for adult patients with Waldenström's Macroglobulinemia (WM) who have received at least one prior treatment, under specific conditions where bendamustine plus rituximab is also deemed suitable. These positive regulatory milestones in key European markets represent substantial progress for BRUKINSA®'s market access and potential commercialization.
Key Highlights
- 1European Medicines Agency (EMA) CHMP issues positive opinion for BRUKINSA® (zanubrutinib) for Marginal Zone Lymphoma (MZL).
- 2BRUKINSA® recommended for adult MZL patients who have received at least one prior anti-CD20-based therapy.
- 3National Institute for Health and Care Excellence (NICE) recommends BRUKINSA® for Waldenström's Macroglobulinemia (WM) in adults.
- 4NICE recommendation for WM is for patients with at least one prior treatment and contingent on bendamustine plus rituximab suitability.
- 5These announcements indicate positive steps towards market access and potential reimbursement for BRUKINSA® in Europe.
- 6The filing incorporates two press releases detailing these regulatory achievements.