European approval for Imbruvica against rare lymphoma

Janssen has gained European approval for its blood cancer drug Imbruvica to be used to treat a rare, slow-growing non-Hodgkin lymphoma.

Patients with Waldenström’s Macroglobulinemia (WM) can now be treated with the drug if they have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

Until now there were no EC-approved treatment options available for patients with the disease, which is diagnosed in 400 patients every year in the UK, and most commonly affects over-65s.

Imbruvica (ibrutinib) is one of a new generation of treatments for chronic lymphocytic leukaemia (CLL), the most common form of leukaemia, but Janssen and its rivals are also targeting rarer blood cancers such as WM. Imbruvica is also licensed to treat relapsed or refractory mantle cell lymphoma.

Dr Rebecca Auer, Clinical Senior Lecturer at Queen Mary University, said: “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.”

Imbruvica is yet to be reviewed by NICE, but last month its rival, Gilead’s Zydelig, was given a preliminary rejection by the UK cost effectiveness body. NICE said it was minded to say no to Zydelig unless the company could provide further data for the drug.

Analysts believe Imbruvica could hit peak annual sales of around $3.5 billion. The drug was discovered by Pharmacyclics, which holds the US marketing rights, and the promise of Imbruvica persuaded AbbVie to buy Pharmacyclics earlier this year for $21 billion.

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