FDA Approves Revlimid (Lenalidomide) for Mantle Cell Lymphoma

Nick Mulcahy


June 05, 2013

There is now another treatment option for patients with mantle cell lymphoma (MCL) who relapse or progress on standard therapy: lenalidomide (Revlimid, Celgene).

The US Food and Drug Administration (FDA) today approved lenalidomide, which comes in a capsule form, for patients with MCL whose disease has relapsed or progressed after 2 prior therapies, one of which included bortezomib (Velcade, Takeda).

Bortezomib is only other drug formally approved for MCL. Treatment options are greatly needed in MCL, which is one of the rarest non-Hodgkin's lymphomas.

The new approval is based a single-group, multicenter clinical trial of heavily pretreated patients, which was presented at the 2012 annual meeting of the American Society of Hematology (ASH) and reported at the time by Medscape Medical News.

All 134 patients in the trial received prior treatment with bortezomib, and 60% were documented to have disease refractory to bortezomib therapy. Patients received a median of 4 prior therapies for MCL.

"This is a very difficult population of patients," said the trial's lead investigator Andre Goy, MD, when the study results were presented at ASH. He is from the John Theurer Cancer Center in Hackensack, New Jersey.

The overall response rate with lenalidomide was 26%; either a complete response or complete response unconfirmed was achieved by 9 patients (7%). In addition, 25 patients (19%) achieved a partial response. The median duration of response for the 34 patients who achieved some kind of response was 16.6 months.

The median duration of therapy was 95 days (range, 1 - 1002 days), and 58% of patients received 3 or more cycles of therapy.

More than half (57%) of the patients underwent at least a single dose interruption because of adverse events, and more than a third (38%) underwent at least a single dose reduction because of adverse events. Nearly a fifth (19%) discontinued treatment entirely because of adverse events.

The most common (≥15%) grade 1 through 4 adverse reactions included neutropenia, thrombocytopenia, fatigue, anemia, diarrhea, nausea, cough, pyrexia, rash, dyspnea, pruritus, constipation, peripheral edema, and leukopenia.

The most common (≥5%) grade 3 through 4 adverse reactions were neutropenia, thrombocytopenia, anemia, pneumonia, leukopenia, fatigue, febrile neutropenia, dyspnea, and diarrhea.

The median age of the patients was 67 years; 81% were men, 96% were white, and 61% had MCL for at least 3 years.

The recommended dose and schedule for lenalidomide is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles. Lenalidomide should be taken at about the same time each day, either with or without food.

The FDA also approved a new 20-mg capsule strength of lenalidomide.

Full prescribing information is available on the FDA Web site.

Both lenalidomide and bortezomib are currently marketed for multiple myeloma.


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