Celgene has announced that the US Food and Drug Administration (FDA) has approved Revlimid (lenalidomide) in combination with rituximab (R2) for patients with previously treated follicular lymphoma (FL) and marginal zone lymphoma (MZL), two forms of indolent non-Hodgkin’s lymphoma (NHL). This follows a priority review designation.
This makes R2 therapy the first FDA-approved combination therapy for these types of indolent NHL, not including chemotherapy.
Lymphoma Research Foundation CEO Meghan Gutierrez said: “Chemotherapy continues to be a standard of care for indolent forms of NHL, but most patients will relapse or become refractory to their current treatment.
“This approval represents a new therapeutic option for previously treated patients with follicular and marginal zone lymphomas, including those who relapse or no longer respond to initial treatment.
“We commend the patients and scientists who participated in the clinical study for advancing lymphoma research and treatment.”
The approval was based upon the results of two trials. In the first, Phase III AUGMENT trial R2met the primary endpoint of progression-free survival (PFS) according to an independent review committee’s evaluation.
Median PFS for the R2group was 39.4 months, compared to 14.1 months for rituximab combined with placebo.
Overall response rate (ORR) for FL patients in the AUGMENT trial was 80% for the drug arm and 55.4% for the placebo arm. It reached 65% for R2 and 44% for the placebo arm in MZL patients.
In the second MAGNIFY trial, which only had one arm, ORR was 59% for FL patients and 51% for MZL patients.
Revlimid is already approved for two other oncology indications: multiple myeloma and mantle cell lymphoma. As it is similar to thalidomide, which is known to cause birth defects, the drug cannot be taken by pregnant women.
Celgene chief medical officer Jay Backstrom said: “Nearly 15 years following the initial FDA approval, Revlimid continues to demonstrate benefits for new patient populations.
“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.”