FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy.
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ABSTRACT:
SUBMITTER: Bhatnagar V
PROVIDER: S-EPMC5679834 | biostudies-literature | 2017 Nov
REPOSITORIES: biostudies-literature
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FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy.
Bhatnagar Vishal V Gormley Nicole J NJ Luo Lola L Shen Yuan Li YL Sridhara Rajeshwari R Subramaniam Sriram S Shen Guoxiang G Ma Lian L Shord Stacy S Goldberg Kirsten B KB Farrell Ann T AT McKee Amy E AE Pazdur Richard R
The oncologist 20170913 11
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 based on two randomized, open-label trials in which daratumumab was added to these backbone therapies. The MMY3003 trial demonstrated substantial improvement in progression-free survival (PFS) when daratu ...[more]
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