The European Commission has approved Revlimid (lenalidomide), produced by Celgene, for adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, including bortezomib.
Refractory mantle cell lymphoma (MCL) is a rare form of non-Hodgkin’s lymphoma and particularly difficult to treat, with limited therapeutic options due to the rapid development of resistance against the most widely used chemotherapy, bortezomib.
“New treatment options are vitally needed in order to change the course of MCL for patients, given the severity of the disease,” Professir Marek Trneny, with the Department of Hematology at Charles University in Prague, and principal investigator in the study that lead to the drug’s approval, said in a press release. “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).”
The comission’s decision was based on the results from MCL-002 (SPRINT, NCT00875667), a randomized Phase 2 study that examined the efficacy and safety of Revlimid versus investigator’s choice of single-agent therapy in 254 patients, ages 18 or older, with relapsed or refractory mantle cell lymphoma.
Patients ineligible for intensive chemotherapy or stem-cell transplantation had longer progression-free survival, with a manageable safety profile, when treated with Revlimid (8.7 months) compared with choice monotherapy options (5.2 months).
Treatment-related adverse events occurred more often in the Revlimid group, and included neutropenia (50.9%), anemia (28.7%), diarrhea (22.8%), fatigue (21.0%), constipation (17.4%), pyrexia (16.8%), and rash (16.2%).
The approval marks the sixth new product or indication approved for Celgene in the last 18 months in the European Union, and follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP).
“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,” said Tuomo Pätsi, president of Celgene in Europe, Middle East and Africa (EMEA). “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 also indicated for the treatment of patients with relapsed/refractory MCL in the United States, Australia, Turkey, Israel and Switzerland, as well as some Latin American countries.