The U.S. Food and Drug Administration (FDA) has granted priority review to Revlimid (lenalidomide) in combination with Rituxan (rituximab) for patients with previously treated follicular and marginal zone lymphoma.
A decision on whether to approve the treatment combination is expected by June 27.
Celgene’s supplemental New Drug Application was based on results from a double-blind Phase 3 study (NCT01938001), named AUGMENT, which assessed the efficacy and safety of adding Revlimid to treatment with Biogen and Genentech’s Rituxan in patients with relapsed or refractory follicular and marginal zone lymphoma — two types of slow-growing, or indolent, non-Hodgkin’s lymphoma.
All 358 participants had received at least two prior doses of Rituxan and showed a response to this therapy.
The trial’s primary endpoint, or goal, was to determine whether the combination treatment was better than Rituxan alone at delaying disease progression or death. Secondary endpoints included overall response rate, complete response rate — the proportion of patients showing disappearance of all cancer signs — duration of response, overall and event-free survival, as well as time to the next anti-lymphoma therapy.
The results revealed that compared to treatment with Rituxan and placebo, the combination of Revlimid and Rituxan (R2) delays disease progression. The safety results were in line with the known profiles of both medications.
Response rates to Rituxan alone in lymphoma patients may be as high as 90% if used with chemotherapy. However, this can induce toxicity and compromise a patient’s immune system, increasing the risk of infections.
“R2 has the potential to offer patients with previously treated follicular lymphoma and marginal zone lymphoma a chemotherapy-free option,” Jay Backstrom, MD, Celgene’s chief medical officer and head of global regulatory affairs, said in a press release. “We look forward to working with the FDA to bring the R2 regimen to patients as quickly as possible.”
These findings had been presented at the 2018 American Society of Hematology (ASH) Annual Meeting and Exposition last December.
Earlier this year, the European Medicines Agency accepted Celgene’s Marketing Authorization Application for the R2 therapy in the same indications.
The company also announced that it expects to submit a Biologics License Application to the FDA in April, covering luspatercept as a treatment for adults with anemia related to very low to intermediate myelodysplastic syndromes with ring sideroblasts — a type of red blood cell precursor — who require red blood cell transfusions, and in adults with anemia related to beta-thalassemia who also need regular red blood cell transfusions.
Luspatercept is being developed by Acceleron Pharma and Celgene.
