Celgene’s Revlimid (Lenalidomide) + Rituximab Receive FDA’s Approval for Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma in Adults

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

Click here to read full press release/ article | Ref: Celgene | Image: Specialty Pharma Journal