J&J leukaemia drug gets FDA go-ahead
pharmafile | January 30, 2015 | News story | Sales and Marketing | FDA, J&J, JJ, Janssen, The US Food and Drug Administration has shown Janssen’s leukaemia drug Imbruvica the green light to treat patients with waldenström’s macroglobulinemia (WM) – a rare indol, Waldenström’s Macroglobulinemia, ibrutinab, imbruvica, johnson
The US Food and Drug Administration has shown Janssen’s leukaemia drug Imbruvica the green light to treat patients with waldenström’s macroglobulinemia (WM) – a rare indolent type of B-cell lymphoma.
Imbruvica (ibrutinab) is the first approved therapy for the disease and represents the fourth indication for the capsule developed by Johnson & Johnson’s pharma unit Janssen.
The treatment which was granted a breakthrough therapy designation by the FDA, works as a protein inhibitor, blocking signals that tell malignant cells to multiply and spread uncontrollably.
“WM patients and physicians have been waiting for a treatment specifically studied and approved to treat this rare disease,” says Carl Harrington, who is the president of the International Waldenström’s Macroglobulinemia Foundation.
“The approval of Imbruvica is an important milestone for the entire global WM community and has the potential to positively impact our patients, their physicians and caregivers.”
Approval was based on the efficacy outcomes from a Phase II study which included 63 patients with previously treated WM. Results demonstrated that just over half of patients achieved a partial response (PR) – a decrease in the size of a cancerous tumour or cell – and 11% achieved a very good PR.
According the drug’s co-developer Pharmacyclics, this year’s US net revenue for the treatment is predicted to reach around $1 billion. A similar drug in development from rival pharma firms are Roche and AbbVie’s BCL-2 inhibitor ABT-199/GDC-0199.
WM affects around 1,500 people a year in the US, it is a cancer that grows mainly in the bone marrow, where they can crowd out the normal cells that make the different types of blood cells.
The disease can also cause low numbers of white blood cells, which makes it hard for the body to fight infection. The numbers of platelets in the blood can also drop, leading to increased bleeding and bruising.
Typically, patients with WM are diagnosed after developing symptoms associated with the disease such as anaemia, fatigue and night sweats.
Aside from WM, Imbruvica is also approved for the treatment of mantle cell lymphoma and chronic lymphocytic leukaemia – the most common type that affects about 2,700 people in the UK.
Tom Robinson
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