Celgene says its Revlimid gets European approval to treat rare non-Hodgkin’s lymphoma
pharmafile | July 15, 2016 | News story | Medical Communications, Research and Development, Sales and Marketing | Celgene, European Commission, Revlimid, drug approval, drug trial, oncology
Celgene (Nasdaq: CELG) said the European Commission (EC) has approved Revlimid (lenalidomide) to treat a rare form of non-Hodgkin’s lymphoma.
Tuomo Pätsi, President of Celgene in Europe, Middle East and Africa, said: “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 a Phase II 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 versus 5.2 in the control arm.
Mantle cell lymphoma (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. 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.
Revlimid is approved in Europe for the treatment of adult patients with previously untreated multiple myeloma (MM) who are not eligible for transplant.
Anjali Shukla
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