The regulator’s decision specifically applies to adult patients with relapsed or refractory disease who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.
CLL is one of the most common types of leukaemia in adults, with about 20,700 new cases of the disease expected to be diagnosed in the US this year.
CLL and SLL are essentially the same diseases that are treated in the same way but are named depending on the location of the patients’ cancer cells. In CLL, the cancer cells are present in the blood and bone marrow, and in SLL, they appear in the lymph nodes.