FDA expands approved use of ibrutinib to waldenström’s macroglobulinaemia

On 29 January, 2015 the USA Food and Drug Administration (FDA) expanded the approved use of ibrutinib (Imbruvica) to treat patients with Waldenström’s macroglobulinaemia. The drug received a breakthrough therapy designation for this use.

Waldenström’s macroglobulinaemia is a rare disease. It accounts for 1%–2% of haematological neoplasms with a reported age-adjusted incidence rate of 3.4 per million among males and 1.7 per million among females in the USA and 7.3 and 4.2 per million European standard population. Waldenström’s macroglobulinaemia is a disease of the elderly with a median age of 63–68 years with a male predominance. Read more here.