FDA approves Imbruvica (Pharmacyclics) for MCL

The FDA have approved Imbruvica (ibrutinib), from Pharmacyclics Inc, as a single agent for the treatment of patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy. This indication is based on overall response rate (ORR). An improvement in survival or disease-related symptoms has not been established.

The FDA's approval is based on a study of 111 patients who were given one ibrutinib capsule daily until their disease progressed or side effects became intolerable. The efficacy results demonstrated a 65.8% overall response rate; 17% of patients achieved a complete response and 49% of patients achieved a partial response. The median duration of response was 17.5 months.