Revlimid Combination Granted Priority Review for Myeloma

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 15 No 4
Volume 15
Issue 4

The FDA has given priority review status to Celgene Corporation's supplemental new drug application for lenalidomide (Revlimid) in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma.

SUMMIT, New Jersey—The FDA has given priority review status to Celgene Corporation's supplemental new drug application for lenalidomide (Revlimid) in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma. In two large phase III trials in previously treated myeloma patients, North American Trial MM-009 and International Trial MM-010, the combination showed safety and efficacy. Revlimid, a derivative of thalidomide (Thalomid), is an immunomodulatory drug. It previously received FDA approval for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndrome associated with a deletion 5q cytogenetic abnormality.

Recent Videos
Combining daratumumab with other agents is one strategy that investigators are exploring in the smoldering multiple myeloma field.
A substantial portion of patients who received daratumumab in the AQUILA study were able to delay disease progression to active multiple myeloma.
The approval of daratumumab validates the notion of using limited therapy to help delay progression from smoldering disease to multiple myeloma.
4 experts in this video
4 experts in this video
4 experts in this video
4 experts in this video
4 experts in this video
Andrezj Jakubowiak, MD, PhD, prioritizes KRd-based regimens for the treatment of high-risk newly diagnosed disease in the post-transplant setting.
Although a similar proportion achieved MRD negativity at the 10 to the –6 power, not enough studies have analyzed MRD at this level for multiple myeloma.
Related Content