Imbruvica is a medicine for treating the blood cancers mantle cell lymphoma, chronic lymphocytic leukaemia (CLL) and Waldenström’s macroglobulinaemia (also known as lymphoplasmacytic lymphoma).

An interim analysis of the clinical trial suggested that the risk of sudden or cardiac death in patients on an ACE inhibitor when entering the study was increased in patients randomised to ibrutinib and rituximab, compared to those randomised to fludarabine, cyclophosphamide and rituximab.

After the September plenary, the PRAC discussed emerging information and decided that a review of the additional data is needed before advice to health care professionals and patients could be provided.

While the assessment is ongoing, healthcare professionals should continue to follow the current product information for Imbruvica. Patients are reminded not to stop taking Imbruvica or ACE inhibitors without first consulting their healthcare professional and to seek medical advice if they have questions or concerns.

Further information is available on EMA website