Lenalidomide Approved by FDA for Follicular and Marginal Zone Lymphoma


This thalidomide analogue is also indicated for multiple myeloma and myelodysplastic syndromes.

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Lenalidomide (Revlimid, Celgene Corp.) has been approved in combination with rituximab for patients with previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL). 

The new indication for the thalidomide analogue is based on results from two studies, AUGMENT (NCT01938001) and MAGNIFY (NCT01996865). In AUGMENT, patients that received lenalidomide and rituximab experienced 39.4 months of progression-free survival (PFS), as opposed to patients in the rituximab and placebo combination who experienced roughly 14.1 months of PFS. Furthermore, patients with FL in the lenalidomide arm experienced an 80% objective response rate (ORR), compared with 55% ORR in the control arm. Patients with MZL experienced an ORR of 65% in the lenalidomide arm of the study, compared with 44% ORR in the control arm. 

In MAGNIFY, ORR by investigatory assessment was 59% for patients with FL. The median response rate of this study was not achieved with a median follow-up of 7.9 months. For patients with MZL, ORR by investigator assessment was 51%. Again, median response rate was not achieved in a follow-up of 11.5 months. 

Throughout both trials, the most common adverse reactions included neutropenia, fatigue, diarrhea, constipation, nausea, and cough. 

The recommended lenalidomide dose for FL or MZL is 20 mg once daily orally on days 1 through 21 of a repeated 28-day cycles for up to 12 cycles.

Lenalidomide is contraindicated for pregnant patients or those with demonstrated hypersensitivity to lenalidomide.  

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