European Commission approves tablet formulation of Brukinsa for all approved indications – BeOne Medicines

BeOne Medicines Ltd. announced that the European Commission has approved a new film-coated tablet formulation of Brunkinsa (zanubrutinib) for all approved indications.

“Developed to meet the real-world needs of patients, the new Brukinsa tablet formulation aims to simplify treatment, reduce pill burden, and enhance ease of administration, reflecting our continuous focus on patient-centered innovation,” said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. “With more than 200,000 patients treated globally and the broadest label of any BTK inhibitor in Europe, Brunkinsa’s differentiated clinical profile continues to make an impact for people facing certain B-cell cancers.”

The recommended dose of Brunkinsa continues to be 320 mg daily. The Brukinsa tablets are 160 mg each, allowing patients to halve their daily pill intake from four pills to two. Additionally, they are smaller than the capsules and have film coatings, which make them easier to swallow. Brukinsa has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. The global Brukinsa clinical development program includes approximately 7,100 patients enrolled in 30 countries and regions across more than 35 trials. Brukinsa is approved for at least one indication in more than 75 markets, and more than 200,000 patients have been treated globally.