European Commission: Revlimid approved for the treatment of relapsed / refractory patients with mantle cell lymphoma
The European Commission ( EC ) has approved Revlimid ( Lenalidomide ) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma ( MCL ).
Mantle cell lymphoma is a rare sub-type of aggressive non-Hodgkin's lymphoma ( NHL ), which starts in the lymph nodes but can move to other organs, causing tumours known as lymphomas.
Between 3 and 6% of NHL patients have mantle cell lymphoma.
Mantle cell lymphoma has the poorest long-term survival of all B-cell lymphoma subtypes, with fewer than 50% of patients surviving at 5 years.
In Europe there were 93,433 new cases of non-Hodgkin lymphoma, and 37,900 deaths in 2012.
Mantle cell lymphoma has a median age of onset of 70 years and affects men more often than women.
The EC decision was based on data from MCL-002, a phase II, multicenter, randomized open-label study to determine the efficacy and safety of Lenalidomide versus the investigator's choice, in 254 patients who were refractory to their last treatment or had relapsed one to three times.
In the study, Lenalidomide showed a significant improvement in progression-free survival ( PFS ) of 8.7 months versus 5.2 in the control arm ( hazard ratio, HR = 0.61, p value of .004 ).
In the study, the most frequently observed adverse reactions which occurred more frequently in the Lenalidomide arm compared with the investigator's choice arm were neutropenia ( 50.9% ), anaemia ( 28.7% ), diarrhoea ( 22.8% ), fatigue ( 21.0% ), constipation ( 17.4% ), pyrexia ( 16.8% ), and rash ( 16.2% ).
The EC decision for the use of Revlimid in adult patients with relapsed/refractory mantle cell lymphoma follows the positive opinion issued by the Committee for Medicinal Products for Human Use ( CHMP ) earlier this year. ( Xagena )
Source: Celgene, 2016