Janssen Launches Imbruvica, First-in-Class Treatment for Patients with CLL and MCL in UK

Today, Janssen has announced that 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 mantle cell lymphoma (MCL) or chronic lymphocytic leukaemia (CLL) who have received one prior therapy or first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. The launch of ibrutinib provides an effective new treatment option for eligible patients. There are 2,800 CLL and 500 MCL 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 CLL 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. 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. 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.