China-based biotech BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the National Institute for Health and Care Excellence (NICE) in the UK has issued a final draft guidance (FDG) recommending the company’s Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) for the treatment of eligible adult patients with untreated chronic lymphocytic leukemia (CLL).
Recommendations and Treatment Indications
The FDG specifically recommends Brukinsa for use in patients with untreated CLL who have a 17p deletion or TP53 mutation. For patients without these genetic markers, Brukinsa is recommended for those not responding to standard treatments such as fludarabine-cyclophosphamide-rituximab (FCR) or bendamustine plus rituximab (BR).
Global Approval and Market Presence
Brukinsa has already secured approval in 65 markets worldwide, including the US, China, EU, UK, Canada, Australia, South Korea, and Switzerland, for various indications. Earlier this month, it received approval in Scotland for the treatment of CLL in adult patients unsuitable for chemo-immunotherapy, further expanding its global footprint and treatment options for patients.-Fineline Info & Tech
