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

Abstract

This article provides a summary of the U.S. Food and Drug Administration (FDA) review of the marketing application for lenalidomide as maintenance therapy for patients with newly diagnosed multiple myeloma after autologous hematopoietic stem cell transplantation.

Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials

“…Our analyses also demonstrated that, on multivariate analysis, 32 Similar findings were reported from a metaanalysis of consolidation plus lenalidomide maintenance vs lenalidomide maintenance alone, 33 although preliminary findings from the EMN02/HOVON-95 study showed contrasting results, with VRD vs no consolidation, followed by lenalidomide maintenance, resulting in improved PFS in patients aged ≤65 years. 34 Lenalidomide was approved as post-ASCT maintenance therapy in 2017 35 and was not a standard of care at the time of the MMY3012 and MMY3013 studies. Since then it has been shown to offer significant improvements in PFS and OS post-ASCT vs placebo/observation, including PFS benefits in patients aged both <60 and ≥60 years.…”

Magnetic Resonance Imaging of Bone Marrow and its Results as a Criterion for Administration of Maintenance Therapy After Auto-HSCT in Multiple Myeloma Patients

“…Результаты большинства проведенных рандомизированных клинических исследований свидетельствовали об улучшении показателей ВБП у больных ММ, получавших после аутоТГСК поддерживающее лечение [13,15,[28][29][30]. Улучшение показателей ОВ определено в опубликованном в 2017 г. P. McCarthy метаанализе, в который было включено 1208 больных ММ, рандомизированных на проведение поддерживающего лечения леналидомидом после аутоТГСК или без посттрансплантационной терапии.…”

Hematopoietic Stem Cell Transplantation in Multiple Myeloma in the Era of Novel Therapies

“…In February 2017, the Food and Drug Administration in the USA approved the use of lenalidomide as maintenance therapy after autologous HSCT for patients with MM, after showing efficacy and safety in several studies [131]. Lenalidomide has tumoricidal and immunomodulatory activities against MM [132].…”