Mantle cell lymphoma: lenalidomide gets EU approval18 Jul 2016
Celgene has announced that the European Commission (EC) has approved REVLIMID® (lenalidomide) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
MCL is a rare subtype of aggressive non-Hodgkin's lymphoma (NHL), which starts in the lymph nodes but can move to other organs, causing tumors known as lymphomas. Between 3 and 6% of NHL patients have MCL. MCL 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 20122. MCL has a median age of onset of 70 years and affects men more often than women.
"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."
Lenalidomide significantly improved progression-free survival
The EC decision was based on data from MCL-002, a phase 2, multicenter, randomized open-label study to determine the efficacy and safety of REVLIMID® versus the investigator's choice (IC), in 254 patients who were refractory to their last treatment or had relapsed one to three times. In the study, REVLIMID® showed a significant improvement in progression-free survival of 8.7 months vs. 5.2 in the control arm.
In the study, the most frequently observed adverse reactions which occurred more frequently in the REVLIMID® arm compared with the IC arm were neutropenia (50.9%), anemia (28.7%), diarrhea (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 MCL follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) earlier this year. In addition to the EU approval, REVLIMID® is indicated for the treatment of patients with relapsed/refractory MCL in the United States, Switzerland, Israel, Turkey, Australia, and numerous countries in Latin America. REVLIMID® is also indicated in various countries including the EU for the treatment of newly diagnosed and relapsed/refractory multiple myeloma and myelodysplastic syndromes.Source: Medical News Today