More than a year after scoring an approval for Brukinsa in Waldenstrom macroglobulinemia (WM) in the U.S., BeiGene appears poised to launch in that use in the U.K.

Tuesday, England’s National Institute for Health and Care Excellence (NICE) signed off on the BTK inhibitor as a second-line treatment for WM, provided that the chemotherapy bendamustine plus rituximab is also appropriate for the patient.

With the decision, Brukinsa becomes the only treatment for WM to be recommended for routine use in England and Wales.

There is a high unmet need for treatment, NICE noted, where “current chemotherapy options can cause severe adverse reactions and the need for frequent hospital visits.”

WM is a rare type of B-cell lymphoma that affects less than 2% of those with non-Hodgkin lymphomas. Approximately 4,000 people in the U.K. have the disorder. It typically attacks bone marrow, and most with the disease are between the ages of 60 and 70, with males nearly twice as likely as females to get it.  

NICE called Brukinsa a “step change” in management of the disease, giving patients a chance to live longer and providing a better quality of life compared to standard of care. England’s price and cost watchdog also noted that Brukinsa is cost efficient at a range of 20,000 pounds sterling to 30,000 pounds ($22,808 to $34,212) per quality-adjusted life year.

When Brukinsa won approval in the U.S. for mantle cell lymphoma in 2019, it became the first cancer drug developed in China to pass muster with the FDA. Two weeks apart in September of last year, Brukinsa won green lights from the FDA to treat WM and marginal zone lymphoma.

As a result, Brukinsa’s sales are rapidly accelerating. In 2021, Brukinsa sales reached $218 million, up from $42 million the previous year. In the second quarter of this year, the drug generated $129 million in sales.

With the momentum, Brukinsa is challenging Johnson & Johnson and AbbVie's megablockbuster Imbruvica, which raked in sales of $9.8 billion last year, ranking No. 7 among the world's best-selling drugs.