Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation 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 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 per cent of NHL patients have MCL. MCL has the poorest long-term survival of all B-cell lymphoma subtypes, with fewer than 50 per cent 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 (PFS).”

Tuomo Pätsi, president of Celgene in Europe, Middle East and Africa (EMEA), adds, “Today is an important milestone in the fight to find new treatment options for patients with MCL, a difficult-to-treat disease with a high unmet medical need. The approval by the European Commission for Revlimid in relapsed/refractory MCL gives us the opportunity to support patients in their fight against this disease, with an innovative treatment, and it is only the beginning of our work to support the needs of patients with MCL. We have a robust clinical program of lymphoma studies reaching patients across the globe with an aim to find new treatment options across numerous types of lymphoma.”

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).

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).

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 treatment of newly diagnosed and relapsed/refractory multiple myeloma and myelodysplastic syndromes.

Revlimid is approved in Europe for the treatment of adult patients with previously untreated multiple myeloma (MM) who are not eligible for transplant. Revlimid is also approved in combination with dexamethasone for the treatment of patients with MM who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

Revlimid is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

In addition, Revlimid is approved in the United States for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In Switzerland, Revlimid is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.