Celgene Corporation has announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Revlimid (lenalidomide) in combination with dexamethasone to include patients with newly diagnosed multiple myeloma.
Revlimid in combination with dexamethasone was initially approved by the FDA in 2006 for the treatment of patients with multiple myeloma who have received at least one prior therapy.
“The approval of REVLIMID as an option for use in all patients with multiple myeloma represents a new paradigm in the management of this disease,” said Kenneth Anderson, M.D., Director, Jerome Lipper Multiple Myeloma Center, Dana-Farber/Brigham and Women’s Cancer Center.
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“We now have clinical evidence demonstrating that starting and keeping newly diagnosed multiple myeloma patients on REVLIMID significantly improves progression-free survival.”
The FDA’s approval was based on results from the phase III FIRST trial, which evaluated continuous Revlimid in combination with dexamethasone until disease progression compared with a combination of melphalan, thalidomide, and prednisone in 1,623 patients with newly diagnosed multiple myeloma who were not eligible to receive stem cell transplantation.
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Results showed a median progression-free survival of 25.5 months in the continuous group compared with 21.2 months in those who received melphalan, prednisone, and thalidomide (HR = 0.72; P = 0.0001). The median overall survival 58.9 months in the Revlimid group versus 48.5 months in the melphalan group (HR = 0.75; 95% CI: 0.62 – 0.90).
Patients in the continuous Revlimid arm also had a 25% risk reduction of death compared with those in the melphalan arm.
