- U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) approved BeiGene's ( NASDAQ: BGNE ) Brukinsa to treat adult patients with chronic lymphocytic leukemia (CLL) and adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.
- The MHRA authorization for Brukinsa (zanubrutinib) in Great Britain to treat CLL was backed by data from two global phase 3 trials — SEQUOIA and ALPINE.
- Meanwhile, the approval for MZL was based on data from a phase 2 study called MAGNOLIA.
- BeiGene's said the MHRA approvals follow recent European Commission marketing authorizations for the drug.
- Earlier this year, the U.K.'s drug pricing watch dog National Institute for Health and Care Excellence (NICE), recommended Brukinsa to treat Waldenström's macroglobulinemia (WM) in adults who have had at least one treatment, only if bendamustine plus rituximab is also suitable, the company added.
- BGNE +1.55% to $269.10 premarket Jan. 19
For further details see:
BeiGene Brukinsa gets approval in UK for blood cancer subtypes