The FDA ( Food and Drug Administration ) has granted accelerated approval for Darzalex ( Daratumumab ) to treat patients with multiple myeloma who have received at least three prior treatments.
Darzalex is the first monoclonal antibody approved for treating multiple myeloma.
Darzalex injection, given as an infusion, is a human IgG1k monoclonal antibody ( mAb ) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells.
The safety and efficacy of Daratumumab were demonstrated in two open-label studies.
In one study of 106 participants receiving Daratumumab, 29% of patients experienced a complete or partial reduction in their tumor burden, which lasted for an average of 7.4 months.
In the second study of 42 participants receiving Daratumumab, 36% had a complete or partial reduction in their tumor burden.
The most common side effects of Daratumumab were 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 ).
Blood banks should be informed that patients are receiving Darzalex because the drug may interfere with certain tests that are done by blood banks ( such as antibody screening ) for patients who need a blood transfusion.
Women who are pregnant should not use Darzalex, and women planning to become pregnant should use effective contraceptives during and for at least three months after treatment.
The FDA granted breakthrough designation for this application based on preliminary clinical evidence suggesting that if approved, Darzalex may offer a substantial improvement over available therapies.
Darzalex also received priority review and orphan drug designations.
Darzalex was approved under the agency’s accelerated approval program, which allows the approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. ( Xagena )
Source: FDA, 2015