Andre Goy, MD, Chairman and Director and Chief of Lymphoma at John Theurer Cancer Center, discusses the approval of the immunomodulatory agent lenalidomide (Revlimid).
Lenalidomide was approved by the FDA to treat patients with mantle cell lymphoma who have relapsed or whose disease has progressed after two prior therapies including at least one prior treatment with bortezomib.
Previously, lenalidomide was only approved in the context of multiple myeloma, Goy points out. This marks the first time lenalidomide has been approved in a lymphoma and the second time a drug has been approved in the relapse or refractory setting of mantle cell lymphoma.
It is remarkable, Goy says, that though there was evidence of activity in lymphoma, it took time to generate data from a phase II trial focusing on heavily-pretreated patients having failed standard therapy.
The duration of response is very important in this setting: Chemotherapy demonstrates short clinical benefit, while duration response was over 16 months in this trial with lenalidomide. A subset analysis, which was presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting, showed that regardless of the number of prior therapies, response and duration were similar.