Lenalidomide Approved as Maintenance for Multiple Myeloma Following Transplant

The FDA has approved lenalidomide as maintenance therapy in patients with multiple myeloma following autologous stem cell transplant.

Lenalidomide (Revlimid) has been included in the treatment of patients with multiple myeloma for about a decade now, and the drug has seen rapid expansion in its indications. The latest indication is as maintenance therapy in patients with multiple myeloma following autologous stem cell transplant (ASCT).

The current approval is based on the results of 2 randomized trials that evaluated lenalidomide as maintenance therapy following ASCT in this patient population. While 1 trial (CALGB 100104) showed a 15-month advantage on progression-free survival (hazard ratio [HR], 0.38; 95% CI, 0.27-0.54; P <.001), the other (IFM 2005-02) presented an 18-month advantage (HR, 0.50; 95% CI, 0.39-0.64; P <.001), compared with patients given placebo. Patients in the CALGB trial had a 24-month overall survival advantage, while patients in the IFM trial had an 18-month advantage, compared with patients receiving placebo following ASCT.

“Autologous stem cell transplant after induction therapy is part of the continuum of care for transplant-eligible multiple myeloma patients. However, most patients will still see their disease recur or progress after this treatment,” Philip McCarthy, MD, director of the Blood and Marrow Transplant Center in the Department of Medicine at Roswell Park Cancer Institute, said in an associated press release. “Lenalidomide maintenance therapy, which has been shown to increase progression-free survival following autologous stem cell transplant in clinical trials can be considered a standard of care for these patients.”

Michael Pehl, president of Global Hematology and Oncology for Celgene, said, “By expanding the approval for REVLIMID to include post-transplant maintenance, patients have the potential to maintain those responses and, importantly, delay progression of the disease.”

While lenalidomide is full of promise, cost concerns remain. A study published early last year in Lancet Oncology showed that including the drug in treatment regimens resulted in a significant increase in treatment costs—the combination of carfilzomib, lenalidomide, and dexamethasone could cost anywhere between $126,000 and $256,000.