FDA first as agency expands label on Celgene’s Revlimid in previously treated follicular or marginal zone lymphoma
Celgene has revealed that the FDA has expanded its authorised indications of Revlimid (lenalidomide) to include combination with a rituximab product (R²) as a therapy for previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL), marking the first approval for the US regulator in these indolent forms of non-Hodgkin’s lymphoma (NHL) that does not include chemotherapy.
Phase 3 data submitted in support of the application showed that the combo therapy demonstrated a “statistically significant” improvement in median progression-free survival (PFS) compared to rituximab plus placebo; median PFS for Celgene’s combo stood at 39.4 months, compared to just 14.1 months.
“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,” said Meghan Gutierrez, Chief Executive Officer for the Lymphoma Research Foundation. “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 company also noted that an overall survival benefit was seen with the Revlimid combo despite the fact the study was not designed to accurately detect such a benefit, with 16 patient deaths as opposed to 26 deaths in the rituximab plus placebo group.
“Nearly 15 years following the initial FDA approval, Revlimid continues to demonstrate benefits for new patient populations,” commented Dr Jay Backstrom, Chief Medical Officer for Celgene. “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.”
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