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BRUKINSA® Receives Significant EU Approval for Follicular Lymphoma Treatment

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BRUKINSA® (zanubrutinib), the first and only Bruton’s tyrosine kinase (BTK) inhibitor approved for follicular lymphoma in the European Union, has achieved a major milestone by securing the broadest label of any medicine within its class globally. The European Commission (EC) has granted approval for BRUKINSA® in combination with the anti-CD20 monoclonal antibody obinutuzumab, specifically for treating relapsed or refractory follicular lymphoma in patients who have undergone at least two prior lines of systemic therapy.

This oral treatment marks a significant breakthrough, as it becomes the inaugural BTK inhibitor to gain approval for this indication within the EU and boasts the most extensive label among all similar medications worldwide. Dr. Mehrdad Mobasher, Chief Medical Officer of Haematology at BeiGene, the pharmaceutical company behind BRUKINSA®, remarked on the significance of this achievement, stating that it offers a new and effective treatment option for eligible patients.

What sets BRUKINSA® apart is its unique mechanism of action, which distinguishes it from existing therapies for this indication. It holds particular promise for patients who have not responded to initial treatments or have experienced a relapse.

A Next-Gen BTK Inhibitor’s Success in Follicular Lymphoma Treatment

The approval by the EC was based on encouraging results from the Phase II ROSEWOOD trial, which involved 217 patients. In this trial, the combination of BRUKINSA® and obinutuzumab demonstrated an impressive overall response rate of 69.0 percent. In contrast, obinutuzumab monotherapy achieved a response rate of 45.8 percent. These findings were obtained with a median follow-up duration of approximately 20 months.

One of the distinguishing features of BRUKINSA® is that it is a next-generation BTK inhibitor, engineered and developed to exhibit increased potency and selectivity, along with sustained target inhibition. This design addresses efficacy limitations seen in first-generation BTK inhibitors and mitigates toxicity associated with their off-target effects.

BTK, or Bruton’s tyrosine kinase, plays a pivotal role in the B-cell receptor signaling pathway, regulating cell proliferation and survival in various B-cell malignancies. Dysregulated BTK is observed in many B-cell malignancies, providing cancer cells with survival advantages. BTK inhibitors are targeted therapies that work by inhibiting BTK, thereby reducing the growth and survival of cancerous B cells. BRUKINSA® stands out as the only BTK inhibitor proven effective in the treatment of follicular lymphoma.

Follicular Lymphoma

Breakthroughs in Protein Degradation and Fixed-Duration Therapies

Looking ahead, Dr. Mobasher shared insights into exciting developments in oncology research. Beyond traditional small molecules that inhibit specific proteins or enzymes, researchers are increasingly exploring novel small molecules that catalyze protein degradation. This approach differs from merely binding or blocking a protein, as it has the potential to prevent tumor escape, offering new avenues for therapeutic intervention.

Moreover, there is a growing emphasis on therapeutics offering fixed-duration treatment regimens, which is expected to play a significant role in the future of cancer treatment. BeiGene is actively engaged in developing a differentiated BCL2 inhibitor known as sonrotoclax, which holds promise in this regard.

Recent discussions with BeiGene’s new Vice President of Medical Affairs, in Europe, have also highlighted positive data from an ongoing Phase I/II trial evaluating sonrotoclax. These findings are anticipated to be shared at the upcoming 2023 American Society of Hematology (ASH) meeting next month, further contributing to the evolving landscape of innovative cancer therapies.


Resource: European Pharmaceutical Review, November 21, 2023

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