The data supporting approval was generated in a phase II study in 254 patients who were refractory to their last treatment or had relapsed one to three times.
Patients treated with Revlimid experienced progression-free survival of 8.7 months compared to 5.2 months for investigator's choice of therapy (p=0.004).
The new indication adds to Revlimid's European label of treatment-naive multiple myeloma (MM) and in combination with dexamethasone in MM patients who have received at least one prior line of therapy.
Celgene president in Europe, Middle East and Africa Tuomo Pätsi said: “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."
Revlimid is indicated to treat patients with relapsed/refractory MCL in the US, Switzerland, Israel, Turkey, Australia, and several countries in Latin America.
It is also indicated in various countries including the European Union to treat newly diagnosed and relapsed/refractory multiple myeloma and myelodysplastic syndromes.
Image: Lymph node with mantle cell lymphoma. Photo: courtesy of Gabriel Caponetti.