Investigators from Food and Drug Administration Zero in on Multiple Myeloma (FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma)
By a News Reporter-Staff News Editor at Medical Letter on the CDC & FDA Current study results on Oncology - Multiple Myeloma have been published. According to news reporting from Silver Spring, Maryland, by NewsRx journalists, research stated, "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 news correspondents obtained a quote from the research from Food and Drug Administration, "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 PracticePrior 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. This article provides a summary of the U.S."
According to the news reporters, the research concluded: "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."
For more information on this research see: FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma. Oncologist, 2018;23(6):734-739. Oncologist can be contacted at: Wiley, 111 River St, Hoboken 07030-5774, NJ, USA (see also Oncology - Multiple Myeloma).
Our news journalists report that additional information may be obtained by contacting E.D. Pulte, Food & Drug Administration, Center Drug Evaluat & Res, Silver Spring, MD, United States. Additional authors for this research include A. Dmytrijuk, L. Nie, K.B. Goldberg, A.E. McKee, A.T. Farrell and R. Pazdur.
The direct object identifier (DOI) for that additional information is: https://doi.org/10.1634/theoncologist.2017-0440. This DOI is a link to an online electronic document that is either free or for purchase, and can be your direct source for a journal article and its citation.
Keywords for this news article include: Silver Spring, Maryland, United States, North and Central America, Hemic and Lymphatic Diseases and Conditions, Center for Drug Evaluation and Research, Government Agencies Offices and Entities, Hematologic Diseases and Conditions, U.S. Food and Drug Administration, Vascular Diseases and Conditions, Immunoproliferative Disorders, Lymphoproliferative Disorders, Hematopoietic Stem Cells, Blood Protein Disorders, Hemorrhagic Disorders, Lenalidomide Therapy, Cell Transplantation, Hemostatic Disorders, Regulatory Agencies, Health and Medicine, Drugs and Therapies, Transplant Medicine, Stem Cell Research, Bone Marrow Cells, Cell Transplants, Multiple Myeloma, Paraproteinemias, Pharmaceuticals, Antineoplastics, Biomedicine, Hematology, Placebos, Oncology, Surgery, Food and Drug Administration.
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