Celegene announced that the FDA has approved its supplemental new drug application (sNDA) for Revlimid (lenalidomide) capsules for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
The new indication approval is based on the results of a Phase 2, multicenter, single-arm, open-label study evaluating lenalidomide in patients (N=134) with MCL who had received prior treatment with rituximab, cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib alone or in combination.
The study’s primary endpoint was overall response rate (ORR) based on review of radiographic scans by an independent committee. Study results showed an ORR of 26% (34/133) (95% CI 18.4, 33.9) with a complete response rate (CR/CRu) of 7% (9/133) (95% CI 3.1, 12.5). The median duration of response was 16.6 months (95% CI, 7.7, 26.7).
Revlimid is a thalidomide analogue already approved for multiple myeloma (in combination with dexamethasone) in patients who have received at least one prior therapy, and for transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality.
For more information call (908) 673-9000 or visit www.revlimid.com.