The drug was approved based on results of 2 open-label studies that showed reduction in tumor burden of patients who had previously received multiple lines of therapy.
The FDA today approved daratumumab for patients with multiple myeloma who have previously been treated with at least 3 regimens. Daratumumab, which received breakthrough status 2 years back, is the first monoclonal antibody approved for multiple myeloma.
The approval follows review of 2 open-label studies that included 106 and 42 participants. The first study (phase 2 MMY2002) saw 29% of patients with a complete or partial reduction in tumor burden that was sustained for at least 7.4 months. These patients had received a median of 5 lines of prior therapy. The second study (phase 1/2 GEN501) saw a complete or partial reduction in tumor burden of 36% of patients. These patients had received a median of 4 lines of prior therapy. Today’s approval is the first for a CD38 antibody and comes just 2 months after the drug was submitted for priority review.
Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, hailed daratumumab as another option for patients to turn to when their disease has developed resistance to all other existing therapies.
Some of the side-effects associated with the drug include infusion-related reactions, fatigue, nausea, back pain, fever, and cough. Daratumumab may also result in low counts of infection-fighting white blood cells (lymphopenia, neutropenia, and leukopenia) or red blood cells (anemia), and low levels of blood platelets (thrombocytopenia).
Daratumumab, approved under the FDA’s accelerated approval program, had an orphan drug designation.