Celgene's Revlimid (Lenalidomide) + Rituximab Receive FDA's Approval for Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma in Adults
Shots:
- The approval is based on P-III AUGMENT study results assessing Revlimid + Rituximab (R2) vs rituximab + PBO in patients with previously treated FL & MZL- following its PR designation
- The P-III AUGMENT study results: mPFS (39.4 vs 14.1 mos.); improvement in OS; median follow-up time (28.3 mos.)
- Revlimid is a thalidomide analog and is indicated in combination with rituximab- currently under EMA regulatory review for r/r FL & MZL with its sNDA submission to PMDA of R2 for the treatment of relapsed/refractory indolent B-cell NHL in Japan
Ref: Celgene | Image: Specialty Pharma Journal
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