European Imbruvica approval for Janssen
pharmafile | July 20, 2015 | News story | Medical Communications, Sales and Marketing | B-cell lymphoma, EC, European Commission, Janssen, Waldenström’s Macroglobulinemia, imbruvica, rare cancer
Janssen has received final European sign-off for its oncology treatment Imbruvica (ibrutinib) as a treatment option for adult patients with a rare blood cancer.
The European Commission (EC) approved Imbruvica (ibrutinib) for Waldenström’s macroglobulinemia (WM). It is available for people with WM who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
WM is a slow growing non-Hodgkin lymphoma which develops when plasma cells grow out of control. In the UK, over 400 patients each year are diagnosed with the disease, which is most prevalent in men over 65 years of age, accounting for approximately 2% of all B-cell lymphomas diagnosed in the UK each year.
The treatment,is the first EC-approved treatment for b-cell lymphoma, will be available to patients unsuitable for chemo-immunotherapy.
Dr Rebecca Auer, clinical senior lecturer at Queen Mary University, says: “The EU licence for ibrutinib in Waldenström’s Macroglobulinemia is exciting, as it is the first licensed treatment for this rare disease in the UK. Ibrutinib is an oral and chemotherapy free approach, which has a good response rate and a generally well tolerated safety profile in clinical trials. This is particularly important because drug toxicities can have such a significant impact on a patient’s quality of life.”
Janssen has also won approval in Europe for Imbruvica as a treatment for adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or first line in people with certain mutations who are unsuitable for chemo-immunotherapy.
Imbruvica has recently been approved for the treatment of WM by the FDA, which granted it Breakthrough Therapy Designation in 2013. It has been cited by the company as a key drug in its portfolio in its recent second quarter financial report.
Yasmita Kumar
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