Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Jun;23(6):734-739.
doi: 10.1634/theoncologist.2017-0440. Epub 2018 Feb 7.

FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma

Elizabeth Dianne Pulte  1 , Andrew Dmytrijuk  2 , Lei Nie  2 , Kirsten B Goldberg  2 , Amy E McKee  2 , Ann T Farrell  2 , Richard Pazdur  2
Affiliations

FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma

Elizabeth Dianne Pulte et al. Oncologist. 2018 Jun.

Abstract

On February 22, 2017, the U.S. Food and Drug Administration (FDA) granted approval for the use of lenalidomide as maintenance therapy after autologous hematopoietic stem cell transplantation (auto-HSCT) for patients with multiple myeloma. The approval was based on evidence from two randomized, blinded trials of maintenance lenalidomide versus placebo in patients with myeloma who had undergone auto-HSCT along with a third trial of lenalidomide versus no therapy. Each of the trials demonstrated superior progression-free survival for the patients treated with lenalidomide. The effect on overall survival was mixed, with one trial showing longer overall survival and another showing no effect. Subgroup analysis suggested better results for patients with International Staging System stage I or II disease compared with stage III disease. Safety evaluation did not reveal any new safety concerns. More second primary malignancies were observed in the lenalidomide arm compared with the placebo arm. The FDA concluded that lenalidomide maintenance showed a favorable benefit-to-risk ratio when used as maintenance therapy after auto-HSCT.

Implications for practice: Prior to this approval, there were no U.S. Food and Drug Administration-approved maintenance therapies for patients with multiple myeloma (MM) who have undergone autologous hematopoietic stem cell transplantation (auto-HSCT). Maintenance therapy with lenalidomide after auto-HSCT in patients with MM demonstrated an approximately 15- to 18-month advantage in progression-free survival compared with placebo at the time of the primary analysis. Patients treated with lenalidomide also appeared to have a survival advantage compared with patients treated with placebo. Because of the high rate of relapse of MM in patients following auto-HSCT and because MM is a serious and often fatal disease, these results appear to be clinically meaningful.

Keywords: Lenalidomide; Multiple myeloma; Revlimid.

PubMed Disclaimer

Conflict of interest statement

Disclosures of potential conflicts of interest may be found at the end of this article.

Figures

Figure 1.
Figure 1.
Chemical structure of lenalidomide.
See this image and copyright information in PMC

References

    1. Child JA, Morgan GJ, Davies FE et al. High‐dose chemotherapy with hematopoietic stem‐cell rescue for multiple myeloma. N Engl J Med 2003;348:1875–1883. - PubMed
    1. Moreau P, San Miguel J, Ludwig H et al. Mulitple myeloma: ESMO clinical practice guidelines for diagnosis, treatment, and follow up. Ann Oncol 2013;24(suppl 6):vi133–vi137. - PubMed
    1. Attal M, Lauwers‐Cances V, Hulin C et al. Lenalidomide, bortezomib, and dexamethasone with transplantation for myeloma. N Engl J Med 2017;376:1311–1320. - PMC - PubMed
    1. Rajikumar SV. Multiple myeloma: 2016 update on diagnosis, risk‐stratification, and management. Am J Hematol. 2016;91:719–734. - PMC - PubMed
    1. Gentile M, Vigna E, Recchia AG et al. Role of new drugs incorporated into consolidation and maintenance therapy in transplant‐eligible multiple myeloma. Expert Opin Pharmacother 2014;15:1315–1320. - PubMed