NICE recommends BeiGene's Brukinsa for marginal zone lymphoma

BeiGene's Brukinsa (zanubrutinib), a Bruton’s tyrosine kinase inhibitor, has received a recommendation from the National Institute for Health and Care Excellence (NICE) for treating certain cases of marginal zone lymphoma (MZL). This endorsement marks Brukinsa as the first treatment specifically approved for this particular type of blood cancer. As a result, patients in England with MZL whose condition has not responded to previous treatments now have another option available through the NHS.

MZL, a collection of slow-growing non-Hodgkin lymphomas, affects approximately 2,600 individuals annually in the UK. This disease occurs due to the uncontrollable growth of B cells, leading to the formation of small, painless lumps in lymph nodes. Often diagnosed at an advanced stage, MZL can develop resistance to existing treatments such as chemotherapy.

Brukinsa offers a new treatment approach for MZL patients, allowing them to take the medication at home in the form of once- or twice-daily capsules. This oral administration reduces the need for additional rounds of intravenous chemotherapy, thus minimizing the inconvenience and side effects commonly associated with such treatments.

NICE's decision is anticipated to benefit around 470 patients over the next three years. Clinical trials have shown promising results, with up to 80% of patients responding positively to Brukinsa. Helen Knight, director of medicines evaluation at NICE, stated that the evidence suggests this treatment not only prolongs the time before the disease worsens but also extends patients' overall life expectancy compared to standard care. She emphasized the importance of having effective and safe treatment options that are convenient, particularly for individuals typically diagnosed in their 70s.

In addition to its new application for MZL, Brukinsa is already approved for treating two other blood cancers: chronic lymphocytic leukemia and Waldenstrom’s macroglobulinaemia. The drug's broadened utility highlights its potential impact across multiple hematologic malignancies.

Robert Mulrooney, general manager for the UK and Ireland at BeiGene, expressed his satisfaction with NICE's recognition of Brukinsa's clinical and economic benefits for patients suffering from these three types of blood cancers. This recommendation follows Brukinsa’s recent accelerated approval by the US Food and Drug Administration (FDA) to treat relapsed or refractory follicular lymphoma. The FDA specifically approved Brukinsa for use in combination with Roche’s anti-CD20 monoclonal antibody Gazyva (obinutuzumab) for adult patients who have undergone at least two prior lines of systemic therapy.

In conclusion, NICE's endorsement of Brukinsa for MZL provides a significant advancement in treatment options for patients in England. This new approval, backed by clinical trial evidence, offers hope for those who have not found success with existing therapies. As Brukinsa continues to gain recognition and approval for various blood cancers, its role in improving patient outcomes becomes increasingly evident.