Arzerra takes on physicians' choice of therapy

[Guest guest]

The objective of this Phase III clinical trial is to confirm the response rate

and disease control in the refractory setting through a controlled trial

comparing ofatumumab with the physicians' choice of therapy in

fludarabine-refractory, bulky lymphadenopathy patients.

This study will compare ofatumumab with the physicians' choice of therapy.

The purpose of this study is to confirm the clinical benefit observed in the

pivotal registration study, Hx-CD20-406.

The Committee for Medicinal Products for Human Use (CHMP) required that a

randomized study be conducted in CLL patients with bulky fludarabine-refractory

disease as a specific obligation for grant of conditional approval for ARZERRA

in the European Union (EU).

I find this rather strange...

~chris