FDA Expands Indication for Revlimid® as a Maintenance Treatment for Patients with Multiple Myeloma Following Autologous Stem Cell Transplant
The U.S. Food and Drug Administration (FDA) expanded the existing indication for Revlimid® (lenalidomide) to include use for patients with multiple myeloma as maintenance therapy following autologous stem cell transplant (ASCT). The expanded indication makes Revlimid® the first and only treatment to receive FDA approval for maintenance use following auto-HSCT.1
Autologous stem cell transplant after induction therapy is part of the continuum of care for transplant-eligible multiple myeloma patients because it has been demonstrated to improve patient outcomes.2 Despite improvement with ASCT most patients will still ultimately see their disease recur or progress after treatment. Maintenance therapy, which has been shown to increase progression-free survival following autologous stem cell transplant in clinical trials can now be considered a standard of care for these patients.
The recent FDA approval was based on two large studies including more than 1,000 patients comparing Revlimid® maintenance therapy given until disease progression or unacceptable toxicity after ASCT versus no maintenance. One study demonstrated an average survival without myeloma progression of 5.7 years versus 1.9 years for no maintenance, a difference of 3.8 years. The second study showed an improvement of 3.9 years versus 2 years for no maintenance, a difference of 1.9 years. Although not designed to evaluate overall survival, the first trial showed an average survival of 9.3 years for Revlimid® versus 7 years for no maintenance.
While Revlimid offers benefit as maintenance therapy for multiple myeloma, it does come with risks, namely the increased risk of second primary cancers. Patients should understand and discuss these risks with their treating physician before deciding on treatment.3
2.Cavo M, Palumbo A, Zweegman S, et al. Upfront autologous stem cell transplantation (ASCT) versus novel agent-based therapy for multiple myeloma (MM): A randomized phase 3 study of the European Myeloma Network (EMN02/HO95 MM trial). Abstract #8000. Presented at the 2016 American Society of Clinical Oncology Annual Meeting, Chicago, IL, June 3, 2016.
3.Badros AZ. Lenalidomide in Myeloma — A High-Maintenance Friend, New England Journal of Medicine. 2012; 366:1836-1838.
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