FDA investigating possible increased risk of death with umbralisib in chronic lymphocytic leukaemia study (CLL) (UNITY)

Results from study of its use in combination with a CD20 monoclonal antibody suggest a possible increased risk of death vs. standard treatment. It is not approved for CLL but the findings have implications for its US approved uses (marginal zone lymphoma and follicular lymphoma)

SPS commentary:

Umbralisib, a PI3K delta inhibitor, is not approved in the UK.

Source:

US Food and Drug Administration