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Janssen launches Imbruvica, first-in-class treatment for patients with Chronic Lymphocytic Leukaemia (CLL) and Mantle Cell Lymphoma (MCL) in UK

Imbruvica® (ibrutinib), an oral, once-daily, first- in-class treatment, has been launched in the UK. It is specifically licensed for patients with relapsed or refractory (MCL) or () who have received one prior therapy or first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.[1] The launch of ibrutinib provides an effective new treatment option for eligible patients. There are 2,800 CLL[2] and 500 MCL[3] patients diagnosed each year in the UK.

Dr Clare Dearden, Consultant Haematologist and Clinical Head of the Haemato-Oncology Unit at the Royal Marsden Hospital, said: “The launch of ibrutinib in the UK signals a real step change in Chronic Lymphocytic Leukaemia treatment and is encouraging for patients and their families. Historically there have been few treatment options beyond chemotherapy, which can have significant side effects and may not be suitable or effective for all patients. This new treatment not only shows good efficacy but it is also generally well tolerated. It therefore has the potential to meet a significant unmet need for selected patients with this disease.”

The licensing of ibrutinib to treat patients with MCL and CLL was granted based on the results of two separate trials. Patients with relapsed or refractory CLL took part in the RESONATE trial, an open-label, randomised, international, multicentre, phase III trial involving 391 patients treated with ibrutinib as monotherapy or ofatumumab monotherapy.[4] The results showed a significant reduction in the risk of progression or death in patients who were treated with ibrutinib, with overall survival also significantly prolonged compared to ofatumumab.[4] The trial was halted early by the Independent Data Monitoring Committee (IDMC) due to the statistically significant benefits shown in patients receiving ibrutinib compared to ofatumumab.

Ibrutinib was also studied in patients with relapsed or refractory MCL in the PCYC 1104 study, a single- arm, phase II study which enrolled 111 patients.[5] The treatment helped patients reach a median progression free survival of 13.9 months with a response rate of 68%.[5]

Professor Simon Rule, Consultant Haematologist at Derriford Hospital Plymouth, said: “Mantle cell lymphoma is a rare disease that only affects around 500 patients in the UK each year. It is an aggressive, incurable disease for the majority of patients and whilst chemotherapy is active, responses are often incomplete and relapse inevitable. Ibrutinib is a highly active oral therapy with a generally well tolerated safety profile that offers patients a new potential therapy in this disease.”