BeiGene Secures Approval from the European Commission for BRUKINSA® (zanubrutinib) in the Treatment of Relapsed or Refractory Follicular Lymphoma
Saturday, November 18, 2023
BeiGene, Ltd. has announced that the European Commission (EC) has granted marketing authorization for BRUKINSA® (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. This makes BRUKINSA the first Bruton's tyrosine kinase (BTK) inhibitor approved for this indication in the European Union (EU), with the broadest label among medicines in its class globally.
BeiGene, expressed excitement about BRUKINSA becoming available as a treatment option for FL patients in the EU. This approval is significant for providing a new and effective treatment option for patients who have not responded to initial therapies or have experienced a relapse.
The EC approval is based on positive results from the ROSEWOOD Phase 2 study, where BRUKINSA plus obinutuzumab demonstrated a higher overall response rate (69.0%) compared to obinutuzumab alone (45.8%). The median progression-free survival for patients treated with the combination was 28.0 months, compared to 10.4 months for those treated with obinutuzumab alone. The safety profile of BRUKINSA plus obinutuzumab was consistent with previous studies.
BRUKINSA is now approved in the EU for various indications, including as monotherapy for chronic lymphocytic leukemia, for marginal zone lymphoma after one prior anti-CD20-based therapy, and for Waldenström’s macroglobulinemia after one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy.
BeiGene, highlighted the company's commitment to making BRUKINSA available globally, with ongoing regulatory reviews in the U.S., China, Canada, Switzerland, and the United Kingdom for additional indications.
BRUKINSA, a BTK inhibitor, is approved in over 65 markets globally, and its development program includes more than 5,000 subjects enrolled in 29 countries and regions.
Follicular Lymphoma (FL) is the second most common type of non-Hodgkin lymphoma, and BRUKINSA offers a chemotherapy-free, oral treatment option with potential positive impacts on the lives of FL patients in the EU and beyond.
Source: businesswire.com
