FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy

On November 21, 2016, the U.S. Food and Drug Administration granted regular approval to daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was base...

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Bibliographic Details

Published in:	The oncologist (Dayton, Ohio) Ohio), 2017-11, Vol.22 (11), p.1347-1353
Main Authors:	Bhatnagar, Vishal, Gormley, Nicole J., Luo, Lola, Shen, Yuan Li, Sridhara, Rajeshwari, Subramaniam, Sriram, Shen, Guoxiang, Ma, Lian, Shord, Stacy, Goldberg, Kirsten B., Farrell, Ann T., McKee, Amy E., Pazdur, Richard
Format:	Article
Language:	eng
Subjects:	Adult Aged Aged, 80 and over Antibodies, Monoclonal - administration & dosage Antineoplastic Combined Chemotherapy Protocols Bortezomib - administration & dosage Daratumumab Dexamethasone - administration & dosage Disease Progression Disease-Free Survival Drug Approval Drug Resistance, Neoplasm - drug effects Drug Resistance, Neoplasm - genetics Female Humans Male Middle Aged Multiple myeloma Multiple Myeloma - drug therapy Multiple Myeloma - epidemiology Multiple Myeloma - genetics Multiple Myeloma - pathology Regulatory Issues: FDA Thalidomide - administration & dosage Thalidomide - analogs & derivatives United States - epidemiology
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