Additional Relevant Details 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 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 (PFS) of 8.7 months vs. 5.2 in the control arm (HR = 0.61, p value of .004)4.
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%), 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 MCL follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) earlier this year. The EC decision marks the 6th new product or indication granted to Celgene in the last 18 months in the European Union. In 2015, Celgene announced the EC approval of medicines for newly diagnosed multiple myeloma, another form of blood cancer; psoriasis and psoriatic arthritis; a specific subset of acute myeloid leukaemia (AML) patients; and non-small-cell lung cancer (NSCLC).