The European Commission approved lenalidomide for the treatment of adult patients with relapsed/refractory mantle cell lymphoma (MCL), following a recommendation earlier this year from the Committee for Medicinal Products for Human Use.
The approval was based on data from the multi-center, randomized, open-label, phase II MCL-002 study that assessed the efficacy and safety of lenalidomide versus investigator's choice (control) in 254 patients who were refractory to their last treatment or had previously relapsed one to three times.
Lenalidomide demonstrated a significant improvement in progression-free survival compared with the control group: 8.7 months versus 5.2 (hazard ratio = 0.61, p=0.004).
The most common adverse events associated with lenalidomide included neutropenia (50.9%), anemia (28.7%), diarrhea (22.8%), fatigue (21%), constipation (17.4%), pyrexia (16.8%), and rash (16.2%). Lenalidomide carries a boxed warning for embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism.
Lenalidomide is already approved in the United States to treat relapsed/refractory MCL.
Source: Celgene press release, July 15, 2016.