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FDA approves Darzalex for pretreated, refractory multiple myeloma
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The FDA today granted accelerated approval to daratumumab for the treatment of patients with multiple myeloma who have received at least three prior treatments.
Daratumumab (Darzalex, Janssen) is the first monoclonal antibody to receive approval for multiple myeloma, a blood cancer that occurs in infection-fighting plasma cells. The drug — administered as an infusion — directs certain immune system cells to attack cancer cells.
Richard Pazdur
The National Cancer Institute estimates that there will be 26,850 new cases of multiple myeloma and 11,240 multiple myeloma-related deaths this year in the U.S.
“Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Darzalex provides another treatment option for patients with multiple myeloma who have become resistant to other therapies.”
The FDA based its approval in part on the results of two open-label trials.
In the first trial, 29% of the 106 patients assigned daratumumab experienced a complete or partial reduction in their tumor burden lasting a median of 7.4 months.
In the second trial, 36% of the 42 patients assigned daratumumab achieved a complete or partial tumor burden reduction.
The most common adverse events associated with daratumumab included infusion-related reactions, fatigue, nausea, back pain, fever and cough. Daratumumab may also result in blood-related side effects such as lymphopenia, neutropenia, leukopenia, anemia and thrombocytopenia.
Further, blood banks should be alerted if a patient is receiving daratumumab as the drug can interfere with certain tests, such as antibody screening for patients in need of a transfusion, according to the press release. Also, pregnant women should not use daratumumab and women planning a pregnancy are recommended to use effective contraceptives during daratumumab treatment and for at least 3 months after the conclusion of treatment.
Daratumumab was approved under the FDA’s accelerated approval program, which allows for the approval of a drug to treat serious or life-threatening disease based on results of a surrogate endpoint that predict the drug’s efficacy and benefit while confirmatory analyses are ongoing. The agent also received breakthrough therapy designation, priority review and orphan drug designation.