Revlimid Combination Granted Priority Review for Myeloma
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 JerseyThe 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.
FDA Approves Cilta-Cel for Relapsed/Refractory Myeloma After 1 Therapy
April 6th 2024The FDA has approved ciltacabtagene autoleucel for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of treatment, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
Relapsed/Refractory Multiple Myeloma Trial Updates From ASCO 2023
August 7th 2023Experts from Mayo Clinic and The University of Texas MD Anderson Cancer Center discuss results from multiple myeloma trials presented at the 2023 American Society of Clinical Oncology Annual Meeting and how they may apply to clinical practice.
