Celgene's Revlimid has been approved by European regulators to treat patients with relapsed/refractory Mantle Cell Lymphoma (MCL), a rare sub-type of aggressive non-Hodgkin's lymphoma (NHL).
Between three and six percent of NHL patients have MCL, which has the poorest long-term survival of all B-cell lymphoma subtypes, with fewer than 50 percent of patients surviving at five years.
The European Commission cleared Revlimid (lenalidomide) on the back of data from the Phase II MCL-002 trial, designed to assess its efficacy and safety versus the investigator's choice of treatment in patients who were refractory to their last treatment or had relapsed one to three times.
The study showed a significant improvement in progression-free survival (PFS) of 8.7 months vs. 5.2 in the control arm. The most frequently observed adverse reactions which occurred more frequently in the Revlimid arm were neutropenia (50.9 percent), anaemia (28.7 percent), diarrhoea (22.8 percent), fatigue (21 percent), constipation (17.4 percent), pyrexia (16.8 percent), and rash (16.2 percent).
"New treatment options are vitally needed in order to change the course of MCL for patients, given the severity of the disease, and there are still limited existing treatment options," said Prof. Marek Trneny, Charles University in Prague. "Lenalidomide is a proven medicine that has shown efficacy in relapsed/refractory MCL, with the MCL-002 study meeting its primary endpoint of an improvement in progression-free survival (PFS)."
In Europe, Revlimid is already indicated fro the treatment of newly diagnosed and relapsed/refractory multiple myeloma and myelodysplastic syndromes.