Bristol-Myers Squibb Co. (BMY) said the European Commission approved a new indication for Revlimid, in combination with rituximab (anti-CD20 antibody), for adult patients with previously treated follicular lymphoma.
FL is a subtype of indolent, but incurable, non-Hodgkin lymphoma which is associated with immune system dysfunction.
The approval was based primarily on results from the phase 3 Augment study, which evaluated the combination versus rituximab plus placebo. In the study, treatment with the combination demonstrated a statistically significant improvement in the primary endpoint of median progression-free survival, Bristol-Myers said.
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