FDA Expands Indication for Revlimid in Multiple Myeloma

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The combination of Revlimid with dexamethasone, previously approved for treatment in patients with multiple myeloma who received at least 1 prior treatment, has received FDA approval for use in newly diagnosed multiple myeloma patients.

Based on findings from the phase III FIRST trial, the FDA has expanded the indication for Celgene’s Revlimid in combination with dexamethasone to include newly diagnosed multiple myeloma patients.

Revlimid plus dexamethasone was initially approved in 2006 only for use in patients with multiple myeloma who had received at least 1 prior therapy. Revlimid is also under review with the European Medicines Agency to use in the treatment of untreated multiple myeloma in adult patients who are not eligible for transplant.


“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,” Kenneth Anderson, MD, director, of the Jerome Lipper Multiple Myeloma Center at Dana-Farber/Brigham and Women’s Cancer Center, said in a statement. “We now have clinical evidence demonstrating that starting and keeping newly diagnosed multiple myeloma patients on Revlimid significantly improves progression-free survival.”

The FIRST trial evaluated Revlimid with dexamethasone compared with melphalan, prednisone, and thalidomide (MPT) in 1623 newly diagnosed patients who were not candidates for stem cell transplant. The patients were randomized into 3 arms: Revlimid plus dexamethasone in 28-day cycles until disease progression; Revlimid plus dexamethasone in 28-day cycles for 72 weeks; or MPT in 42-day cycles for 72 weeks.

The median progression-free survival was significantly longer for patients receiving Revlimid (25.5 months) compared with those treated with MPT (21.2 months). The overall survival for patients on Revlimid was 58.9 months compared with 48.5 months.

The most common adverse events for patients on Revlimid included diarrhea, anemia, neutropenia, fatigue, and back pain.

“Now, as part of our commitment to improving the lives of patients living with this disease, our next step is to make the benefits of this treatment regimen available to those now eligible under the expanded indication,” said Jacqualyn A. Fouse, PhD, president of global hematology and oncology for Celgene.