Celgene Corporation announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the approval of REVLIMID® in combination with rituximab for the treatment of adult patients with previously treated follicular lymphoma. If approved by the European Commission, R2 will be the first combination treatment regimen for patients with FL that does not include chemotherapy. In FL, a subtype of indolent NHL, the immune system is not functioning optimally. When this dysfunction occurs, the immune system either fails to detect or attack cancerous cells. Rituximab is a monoclonal antibody that targets the CD 20 antigen on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab causes B-cell lysis. Lenalidomide is an immunomodulator that increases the number and activation of T and natural killer (NK) cells, resulting in the lysis of tumor cells. The R2 combination regimen acts by complementary mechanisms to help the patient’s immune system to find and destroy the cancer cells. Given the incurable nature of FL2, a high unmet medical need exists for the development of novel treatment options with new mechanisms of action and a tolerable safety profile to help improve progression-free survival (PFS) especially in the setting of previously treated FL. The estimated incidence of NHL in Europe was 100,055 cases in 2018; FL accounts for approximately 25% of all NHL cases and is the most common form of indolent NHL. The CHMP positive opinion is based primarily on results from the randomized, multi-center, double-blind, Phase 3 AUGMENT study, which evaluated the efficacy and safety of the R² combination versus rituximab plus placebo in patients with previously treated FL (n=295). Additionally, findings from the MAGNIFY study were included as support for the safety and the efficacy of lenalidomide plus rituximab in patients with relapsed or refractory FL, including rituximab refractory FL patients. The CHMP reviews applications for all member states of the European Union (EU), as well as Norway, Liechtenstein, and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months. If approval is granted, detailed conditions for the use of this product will be described in the REVLIMID Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report.