Abstract |
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 daratumumab was added to lenalidomide and dexamethasone compared with lenalidomide and dexamethasone alone. The estimated median PFS had not been reached in the daratumumab arm and was 18.4 months in the control arm (hazard ratio [HR] = 0.37; 95% confidence interval [CI]: 0.27-0.52; p < .0001), representing a 63% reduction in the risk of disease progression or death. Similar results were observed in the MMY3004 trial comparing the combination of daratumumab, bortezomib, and dexamethasone with bortezomib and dexamethasone. The estimated median PFS was not reached in the daratumumab arm and was 7.2 months in the control arm (HR = 0.39; 95% CI: 0.28-0.53; p < .0001), representing a 61% reduction in the risk of disease progression or death. The most frequently reported adverse reactions (greater than or equal to 20%) in MMY3003 were infusion reactions, diarrhea, nausea, fatigue, pyrexia, upper respiratory tract infection, muscle spasm, cough, and dyspnea. The most frequently reported adverse reactions (greater than or equal to 20%) in MMY3004 were infusion reactions, diarrhea, peripheral edema, upper respiratory tract infection, and peripheral sensory neuropathy. Neutropenia and thrombocytopenia have been added to the Warnings and Precautions of the drug label. IMPLICATIONS FOR PRACTICE:
|
Authors | Vishal Bhatnagar, Nicole J Gormley, Lola Luo, Yuan Li Shen, Rajeshwari Sridhara, Sriram Subramaniam, Guoxiang Shen, Lian Ma, Stacy Shord, Kirsten B Goldberg, Ann T Farrell, Amy E McKee, Richard Pazdur |
Journal | The oncologist
(Oncologist)
Vol. 22
Issue 11
Pg. 1347-1353
(11 2017)
ISSN: 1549-490X [Electronic] England |
PMID | 28904172
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
|
Copyright | Published 2017. This article is a U.S. Government work and is in the public domain in the USA. |
Chemical References |
- Antibodies, Monoclonal
- daratumumab
- Thalidomide
- Bortezomib
- Dexamethasone
- Lenalidomide
|
Topics |
- Adult
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
- Bortezomib
(administration & dosage)
- Dexamethasone
(administration & dosage)
- Disease Progression
- Disease-Free Survival
- Drug Approval
- Drug Resistance, Neoplasm
(drug effects, genetics)
- Female
- Humans
- Lenalidomide
- Male
- Middle Aged
- Multiple Myeloma
(drug therapy, epidemiology, genetics, pathology)
- Thalidomide
(administration & dosage, analogs & derivatives)
- United States
(epidemiology)
|
|
Join CureHunter, for free Research Interface BASIC access!
Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease.
Find out why thousands of doctors, pharma researchers and patient activists
around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!
|