FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy
| Autor: | Lola Luo, Sriram Subramaniam, Nicole J. Gormley, Guoxiang Shen, Lian Ma, Rajeshwari Sridhara, Yuan Li Shen, Richard Pazdur, Stacy S. Shord, Kirsten B. Goldberg, Ann T. Farrell, Vishal Bhatnagar, Amy E. McKee |
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| Rok vydání: | 2017 |
| Předmět: |
Male
0301 basic medicine Oncology Cancer Research Peripheral edema Dexamethasone Bortezomib 0302 clinical medicine Multiple myeloma hemic and lymphatic diseases Antineoplastic Combined Chemotherapy Protocols Drug Approval Lenalidomide health care economics and organizations Regulatory Issues: FDA Aged 80 and over Hazard ratio Antibodies Monoclonal Middle Aged Thalidomide 030220 oncology & carcinogenesis Disease Progression Female medicine.symptom medicine.drug Adult medicine.medical_specialty Neutropenia Disease-Free Survival 03 medical and health sciences Daratumumab Internal medicine medicine Humans Aged business.industry medicine.disease United States 030104 developmental biology Drug Resistance Neoplasm business |
| Zdroj: | The Oncologist |
| ISSN: | 1549-490X 1083-7159 |
| DOI: | 10.1634/theoncologist.2017-0229 |
| Popis: | Multiple myeloma is mostly an incurable disease. The U.S. Food and Drug Administration (FDA) granted daratumumab accelerated approval in November 2015 as monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome and an immunomodulatory agent. This article describes the FDA review of the strength of evidence for this application and its clinical implications for the multiple myeloma population. 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 |
| Databáze: | OpenAIRE |
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