The US Food and Drug Administration (FDA) has approved daratumumab (Darzalex, Janssen) in combination with lenalidomide (Revlimid, Celgene) and dexamethasone or with bortezomib (Velcade, Millennium) and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Last year at this time, the FDA approved the monoclonal antibody as a monotherapy for patients with multiple myeloma who have tried at least three other drug therapies.
The new approval is based on results from phase 3 clinical trials.
In the open-label POLLUX clinical trial, daratumumab in combination with lenalidomide and dexamethasone reduced the risk for disease progression or death by 63%, compared with lenalidomide and dexamethasone alone, in patients with multiple myeloma who received a median of one prior therapy (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.27 - 0.52; P < .0001). The trial results were published in The New England Journal of Medicine in October, as reported by Medscape Medical News.
Similarly, in the open-label CASTOR clinical trial, daratumumab in combination with bortezomib and dexamethasone reduced the risk for disease progression or death by 61%, compared with bortezomib and dexamethasone alone, in patients with multiple myeloma who received a median of two prior lines of therapy (HR, 0.39; 95% CI, 0.28 - 0.53; P < .0001). These results were also published in The New England Journal of Medicine in August, as reported by Medscape Medical News.
Updated results from both of these clinical studies will be presented as oral presentations at the upcoming annual meeting of the American Society of Hematology (ASH) in San Diego, California, in early December.
"While tremendous progress in the treatment of multiple myeloma has been made in the past decade, patients and their physicians continue to need new treatment options," said Meletios Dimopoulos, MD, a daratumumab investigator at the National and Kapodistrian University of Athens School of Medicine in Greece, in a company press statement.
"With daratumumab, we have a potential new backbone therapy, which has shown pronounced efficacy as either a single agent or in combination with standard of care regimens," said Dr Dimopoulos.
Overall, the safety of the daratumumab combination therapy was consistent with the known safety profiles of daratumumab monotherapy and lenalidomide plus dexamethasone, respectively. The same held true for the safety of the daratumumab combination therapy with bortezomib plus dexamethasone.
The recommended dose of daratumumab is 16 mg/kg body weight administered as an intravenous infusion. The dosing schedule for daratumumab in combination with lenalidomide and dexamethasone begins with weekly administration (weeks 1 - 8), decreasing in frequency over time to every 2 weeks (weeks 9 - 24), and ultimately every 4 weeks (week 25 onward) until disease progression, according to company press materials.
The dosing schedule for daratumumab in combination with bortezomib and dexamethasone begins with weekly administration (weeks 1 - 9), decreases in frequency over time to every 3 weeks (weeks 10 - 24), and ultimately every 4 weeks (weeks 25 and onward) until disease progression, said the company.
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Cite this: FDA Approves Daratumumab in Multiple Myeloma Combos - Medscape - Nov 23, 2016.