BeiGene announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for BRUKINSA (zanubrutinib) in Great Britain for both the treatment of adult patients with chronic lymphocytic leukemia (CLL) and the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. The MHRA authorization for CLL is based on two global Phase 3 clinical trials: SEQUOIA (NCT03336333)1, comparing BRUKINSA against bendamustine plus rituximab (BR) in patients with previously untreated CLL, and ALPINE (NCT03734016)2, comparing BRUKINSA® against IMBRUVICA® (ibrutinib) in patients with relapsed/refractory (R/R) CLL. The MHRA authorization for MZL is based on results from the multicenter, global, single-arm, open-label, Phase 2 MAGNOLIA3 trial in patients with R/R MZL who received at least one anti-CD-20 based regimen.

Earlier this year, the National Institute for Health and Care Excellence (NICE), recommended BRUKINSA for the treatment of Waldenström's macroglobulinemia (WM) in adults who have had at least one treatment, only if bendamustine plus rituximab is also suitable. BRUKINSA has also been recommended by the Scottish Medicines Consortium for the treatment of adult patients with WM who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemoimmunotherapy. BRUKINSA is currently authorized in the European Union, and Northern Ireland, as per rulings set out in the Northern Ireland Protocol,for the treatment of adult patients with WM who have received at least one prior therapy or as the first-line treatment for patients unsuitable for chemoimmunotherapy; for the treatment of adult patients with CLL and for adult patients with MZL who have received at least one prior anti-CD20-based therapy.