Daratumumab Granted Breakthrough Therapy Designation for Use in Combination Regimens
The FDA granted Breakthrough Therapy Designation to daratumumab in combination for the treatment of patients with multiple myeloma.
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation 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 1 prior therapy.1
This designation was based on findings from 2 phase 3 trials, CASTOR and POLLUX. The CASTOR trial evaluated daratumumab in combination with bortezomib and dexamethasone, compared with bortezomib and dexamethasone alone, for patients who had received at least 1 prior therapy. Preliminary findings presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting showed that the daratumumab combination reduced the risk of disease progression or death.
The POLLUX trial, which was presented at the 2016 European Hematology Association (EHA) Annual Congress, demonstrated that the addition of daratumumab to lenalidomide and dexamethasone reduced the risk of disease progression or death in patients who had received at least 1 prior therapy.
"Daratumumab has already shown pronounced activity as a monotherapy in heavily pre-treated patients. This designation underscores the potential of daratumumab in combination with either a proteasome inhibitor or an immunomodulatory agent to provide much-needed benefit to patients with at least 1 prior therapy," said Dr Meletios A. Dimopoulos, lead study author of POLLUX.
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Daratumumab was granted accelerated approval by the FDA in late 2015 for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. Breakthrough Therapy Designation was previously granted for this indication, as well.
- Daratumumab (DARZALEX®) granted Breakthrough Therapy Designation by U.S. Food and Drug Administration (FDA) for use in combination with standard of care regimens for patients with multiple myeloma [news release]. PRnewswire. http://www.prnewswire.com/news-releases/daratumumab-darzalex-granted-breakthrough-therapy-designation-by-us-food-and-drug-administration-fda-for-use-in-combination-with-standard-of-care-regimens-for-patients-with-multiple-myeloma-300303669.html. Updated July 28, 2016. Accessed July 28, 2016.