The approval of R2 is based on data from the phase 3 AUGMENT study evaluating the safety and efficacy of the combination regimen compared with rituximab plus placebo in patients with previously-treated FL and MZL.
Officials with the FDA today approved lenalidomide (Revlimid, Celgene) in combination with a rituximab product (R2) for the treatment of adult patients with previously-treated follicular lymphoma (FL) or marginal zone lymphoma (MZL), according to a press release.
R2 previously received Priority Review designation from the FDA. With this approval, this is the first combination regimen for patients with these indolent forms of non-Hodgkin lymphoma (NHL) that does not include chemotherapy. Indolent lymphomas, which account for approximately 40% of all NHL cases, are slow-growing forms of the disease, which can often be asymptomatic or have fewer symptoms upon diagnosis. Most patients with indolent forms of NHL will relapse or become refractory to their current treatment, according to Celgene.
“Nearly 15 years following the initial FDA approval, Revlimid continues to demonstrate benefits for new patient populations,” Jay Backstrom, MD, MPH, chief medical officer for Celgene, said in a statement. “Revlimid in combination with rituximab (R2) leads to immune-mediated treatment effects and represents a chemotherapy-free treatment option that can help patients with previously-treated follicular lymphoma and marginal zone lymphoma delay disease progression.”
A version of this article was originally published by Specialty Pharmacy Times. View the entire article at SpecialtyPharmacyTimes.com.