Waldenstrom's macroglobulinaemia recurrent

BeiGene’s Brukinsa (zanubrutinib) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat certain cases of marginal zone lymphoma (MZL). The Bruton’s tyrosine kinase inhibitor, which is the first treatment to be specifically licensed for this form of blood cancer, is now available on the NHS in England as an additional option for patients whose cancer has not responded well to previous treatment. Approximately 2,600 people are diagnosed every year in the UK with MZL, a group of slow-growing non-Hodgkin lymphomas that develop when there is uncontrollable growth in B cells. The disease is often diagnosed at a more advanced stage due to the main symptom being small, painless lumps in lymph nodes, and some patients become resistant to current treatments, including chemotherapy. Brukinsa can be taken at home as either once- or twice-daily capsules, providing an alternative to further rounds of chemotherapy and potentially reducing the inconvenience and side effects of intravenous treatment. NICE’s decision, which is expected to benefit about 470 patients over the next three years, was supported by clinical trial results showing that up to 80% of patients’ cancers responded to BeiGene’s drug. Helen Knight, director of medicines evaluation at NICE, said: “Evidence suggests that this treatment increases how long people have before their condition gets worse and increases how long they live compared with standard care. “People with MZL are typically diagnosed in their 70s, so there is a need for effective and safe treatment options that are convenient for them to take.” Brukinsa is already available to treat two other blood cancers: chronic lymphocytic leukaemia and Waldenstrom’s macroglobulinaemia. Robert Mulrooney, general manager UK and Ireland at BeiGene, said: “We are delighted that NICE has recognised the clinical and economic benefit of Brukinsa for eligible patients across three disease areas.” The recommendation comes just a few months after Brukinsa was granted accelerated approval by the US Food and Drug Administration to treat relapsed or refractory follicular lymphoma. The US regulator specifically authorised the drug for use alongside Roche’s anti-CD20 monoclonal antibody Gazyva (obinutuzumab) in adult patients who have received at least two prior lines of systemic therapy.

Janssen and Pharmacyclics’ ibrutinib has demonstrated a significant and sustained progression-free and overall survival benefit in patients with previously untreated chronic lymphocytic leukaemia (CLL), according to new long-term results shared by the Johnson & Johnson company. Affecting approximately 4.92 per 100,000 people every year in Europe, CLL is typically a slow-growing blood cancer of the white blood cells. Despite patient outcomes improving significantly over the last few decades, CLL is still characterised by consecutive episodes of disease progression and patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments. Administered orally once daily, ibrutinib is designed to block the BTK protein needed by normal and abnormal B-cells to multiply and spread. The drug already holds approvals to treat treatment-naïve and pretreated CLL, as well as certain patients with mantle cell lymphoma and Waldenström’s macroglobulinaemia. The phase 3 RESONATE-2 trial has been comparing ibrutinib monotherapy against chlorambucil for up to 12 cycles in previously untreated CLL patients aged 65 years and older. The results, presented at this year’s European Hematology Association Congress, showed a median progression-free survival of 8.9 years in the ibrutinib arm versus 1.3 years in the chlorambucil cohort. With up to ten years of follow-up, median overall survival had not been reached with ibrutinib and 27% of patients in the study remained on ibrutinib. The drug was also found to be well tolerated as a long-term treatment and no new safety signals were observed. Commenting on the latest results, clinical study investigator, Alessandra Tedeschi, Niguarda Hospital, said: “When ibrutinib was first introduced more than ten years ago, it changed the course of CLL treatment, and today it remains a central part of the standard of care for patients living with B-cell malignancies. “The final analysis of the RESONATE-2 study confirms the favourable benefit-risk profile of ibrutinib is sustained over time, with the longest follow-up data of any targeted therapy in CLL, and demonstrates its potential to enable patients diagnosed with CLL today to look forward to the possibility of a normalised life expectancy.”

BeiGene notched its fifth US approval for Brukinsa (zanubrutinib) on Thursday when it became the first BTK inhibitor cleared to treat follicular lymphoma (FL). According to the drugmaker, Brukinsa now has the broadest label of all drugs in the class.The FDA granted accelerated approval to Brukinsa in combination with Roche’s anti-CD20 antibody Gazyva (obinutuzumab) to treat relapsed or refractory FL patients after they’ve received two or more lines of systemic therapy. The combination received EU approval in November.Thursday’s greenlight comes a little over a year after its most recent US approval, which was for relapsed/refractory chronic lymphocytic leukaemia. Brukinsa is also approved in both the US and Europe to treat mantle cell lymphoma, Waldenström's macroglobulinaemia and marginal zone lymphoma. For more, see ViewPoints: Safety makes Brukinsa first choice in chronic lymphocytic leukaemia.The latest approval was based on the 217-patient Phase II ROSEWOOD study, in which Brukinsa plus Gazyva led to an overall response rate of 69% versus 46% for Gazyva alone. The combination also saw an 18-month duration of response of 69%.Full approval in FL may depend on the results of the confirmatory Phase III MAHOGANY trial, which is comparing the Brukinsa/Gazyva combo against Revlimid (lenalidomide) plus Rituxan (rituximab).