Janssen Launches Imbruvica, First-in-Class Treatment for Patients with CLL and MCL in UK
![](/46/pdcnewsitem/03/39/89/SNU5SAFpZTebPeW.jpg)
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.
Related News
-
News Global advancements in the diagnosis and treatment of rare diseases: Rare Disease Day 2024
Rare Diseases Day is celebrated on the 29th February 2024 and represents the plight of rare disease patients to gain diagnosis and access to suitable treatment. -
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance