BRUKINSA® granted significant EU approval in follicular lymphoma

The first and only Bruton’s tyrosine kinase (BTK) inhibitor approved for follicular lymphoma in the EU, now has the broadest label of any medicine in its class globally.

BRUKINSA granted “significant” EU approval in follicular lymphoma

BRUKINSA ® (zanubrutinib) in combination with the anti-CD20 monoclonal antibody obinutuzumab, has been approved by the European Commission (EC) to treat relapsed or refractory follicular lymphoma in individuals who have received at least two prior lines of systemic therapy.

The oral treatment is now “the first Bruton’s tyrosine kinase (BTK) inhibitor approved in this indication and has the broadest label of any medicine in its class globally,” stated Dr Mehrdad Mobasher, Chief Medical Officer, Haematology at BeiGene. “This milestone… [provides] a new and effective treatment option to [eligible] patients.”

Speaking to EPR, Dr Mobasher added that the treatment “has a mechanism of action distinct from all other available therapies for this indication, for patients who have either failed to respond to initial therapies or have experienced a relapse”.

Clinical data for BRUKINSA

The EC’s decision is based on positive results from the Phase II ROSEWOOD trial, which compared the combination treatment with obinutuzumab monotherapy in 217 patients. Overall response rate was 69.0 percent in patients treated with BRUKINSA plus obinutuzumab compared with 45.8 percent in obinutuzumab alone, with a median follow-up of approximately 20 months.

A novel BTK inhibitor

Dr Mobasher told EPR that as a next generation BTKI, BRUKINSA was “engineered and developed to have increased potency and selectivity as well as sustained target inhibition to overcome efficacy limitations in first-generation BTK inhibitors and toxicity related to their off-target effects.

BTK is an important enzyme in the B-cell receptor signalling pathway, regulating cell proliferation and cell survival in various B-cell malignancies. Many B-cell malignancies have dysregulated BTK which can provide survival advantages for cancer cells. A BTK inhibitor is a targeted treatment that works to shut down (or inhibit) BTK, reducing the growth and survival of cancerous B cells.”

the only BTK inhibitor that has proven to work in the B-cell cancer follicular lymphoma, is BRUKINSA”

Dr Mobasher continued, emphasising that “the only BTK inhibitor that has proven to work in the B-cell cancer follicular lymphoma, is BRUKINSA.”

Future treatments

Looking to the future of small molecule treatments, Dr Mobasher also told EPR what he considered exciting in oncology research: “Beyond the traditional small molecules that inhibit a protein or enzyme, one of the exciting developments in cancer research are novel small molecules that reduce the activity of target proteins by catalysing protein degradation. This does not just bind or block a protein, as degrading the target has the potential to prevent tumour escape.”

“In addition, an increased focus on therapeutics that offer the potential for fixed duration treatment is expected and we are working on developing a differentiated BCL2 inhibitor, sonrotoclax.”

EPR’s recent article with BeiGene’s new Vice President of Medical Affairs, Europe, discussed positive data from an ongoing Phase I/II trial evaluating sonrotoclax. These findings are expected to be shared at the 2023 American Society of Hematology (ASH) meeting next month.