Darzalex has become the first monoclonal antibody therapy to be approved by the U.S. Food and Drug Administration for the treatment of patients with multiple myeloma who have had three or more previous treatments.
Multiple myeloma is a type of cancer arising from malignant plasma cells in the bone marrow. The exact causes are not fully understood, but scientists believe that most cases occur when certain changes in the DNA trigger the plasma cells to become cancerous. 1
As at 2012, the worldwide estimate of people living with multiple myeloma was nearly 230,000, with about 114,000 new cases diagnosed that same year. 2 And because this disease affects mostly people over 60 years, the overall prevalence is expected to rise as the world’s population ages.
Although the past decade has seen advancement in the treatment of multiple myeloma, the disease remains incurable. 3 More crucial is that treatment options become limited for those with relapsed or refractory multiple myeloma. 3 Hence Darzalex would serve as another treatment alternative for multiple myeloma that are resistant to other treatments.
Darzalex is administered as an infusion and works by attacking cancer cells through the support of certain cells in the immune system
The approval was accelerated under the accelerated approval program based on two open label studies, which demonstrated the safety and efficacy of Darzalex.
Darzalex is marketed by Janssen Biotech of Horsham, Pennsylvania
More details on the approval can be read here: FDA Darzalex accelerated approval
- American Cancer Society. Do we know what causes multiple myeloma? 2015 [assessed 23 November 2015] Available from: http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-causes
- WHO International Agency for Research on Cancer. GLOBOCAN 2012: Estimated Cancer Incidence, mortality, prevalence worldwide in 2012. 2012 [Assessed 23 November 2015] Available from: http://globocan.iarc.fr/
- Hanaizi Z, Flores Beatriz, Hemmings R, et al. The European medicines agency review of pomalidomide in combination with low-dose dexamethasone for the treatment of adult patients with multiple myeloma: summary of the scientific assessment of the committee for medicinal products for human use. The oncologist 2015; 20:329–334