Celgene Global Sàrl, a wholly owned subsidiary of Celgene Corporation has announced that the European Commission (EC) has approved REVLIMID® (lenalidomide) for the treating adult patients with relapsed or refractory cellular lymphoma (MCL) that is mantle.
MCL is a sub-type that is rare of non-Hodgkin's lymphoma (NHL), which starts into the lymph nodes but can proceed to other organs, causing tumours called lymphomas. Between 3 and 6 % of NHL patients have actually MCL. MCL gets the poorest long-lasting survival of all lymphoma that is b-cell, with less than 50 per cent of clients surviving at 5 years1. In Europe there have been 93,433 brand new situations of non-Hodgkin lymphoma, and 37,900 fatalities in 20122. MCL has a age that is median of of 70 years and affects males more often than women3.
"New treatment options are vitally required to be able to change the span of MCL for patients, offered the severity of the illness, and you can still find limited treatment that is existing," stated Prof. Marek Trneny, Charles University in Prague. "Lenalidomide is a medicine that is proven has shown efficacy in relapsed/refractory MCL, because of the MCL-002 study meeting its primary endpoint of a marked improvement in progression-free survival (PFS)."
Tuomo Pätsi, President of Celgene in Europe, center East and Africa (EMEA), adds: "Today is a significant milestone in the fight to find new treatment options for clients with MCL, a difficult-to-treat condition with a top unmet need that is medical. The approval by the European Commission for REVLIMID® in relapsed/refractory MCL gives us the chance to help clients in their fight against this disease, with an treatment that is revolutionary and it is only the start of our work to support the needs of patients with MCL. We now have a robust clinical program of lymphoma studies reaching clients across the globe with an aim to locate therapy that is brand new all-around numerous types of lymphoma."
The EC choice ended up being based on information from MCL-002, a stage II, multicenter, randomized study that is open-label determine the efficacy and safety of REVLIMID® versus the investigator's choice (IC), in 254 patients who had been refractory for their final treatment or had relapsed someone to three times. Into the research, REVLIMID® revealed a improvement that is significant progression-free survival (PFS) of 8.7 months vs. 5.2 in the control supply (HR = 0.61, p value of .004)4.
probably the most frequently seen effects which happened more frequently in the REVLIMID® arm compared with the IC arm were neutropenia (50.9%), anaemia (28.7%), diarrhoea (22.8%), exhaustion (21.0%), constipation (17.4%), pyrexia (16.8%), and rash (16.2%) within the study.
The EC decision for the application of REVLIMID® in adult clients with relapsed/refractory MCL follows the viewpoint that is positive by the Committee for Medicinal goods for Human Use (CHMP) earlier in the day this present year. The EC choice marks the 6th item that is brand new indication given to Celgene within the last few 1 . 5 years in the European Union. In 2015, Celgene announced the EC approval of medicines for newly diagnosed multiple myeloma, another kind of blood cancer; psoriasis and arthritis that is psoriatic a certain subset of severe myeloid leukaemia (AML) clients; and non-small-cell lung cancer (NSCLC).
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 countries which are many Latin America. REVLIMID® is additionally indicated in several countries like the EU for treatment of newly diagnosed and relapsed/refractory myeloma that is numerous myelodysplastic syndromes.