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Lymphoma and Pets
Priority Review Given to Genmab's Multiple Myeloma Treatment
The US FDA has granted Priority Review to Genmab's Biologics License Application (BLA) for the company's investigational treatment for multiple myeloma, daratumumab.
The application is for daratumumab as a treatment for patients with multiple myeloma who have received at least three different lines of therapy, including both a proteasome inhibitor and an immunomodulatory agent (IMiD), or for patients who are double-refractory to a proteasome inhibitor and an IMiD.
Daratumumab is an investigational human IgG1k monoclonal antibody that binds to the CD38 molecule. CD38 is highly expressed on the surface of multiple myeloma cells. Upon binding, it induces rapid tumor cell death.
Priority Review means that the FDA regards the drug as being that treats a serious condition and that may provide a significant improvement in safety or efficacy over what is currently on the market.
"We are pleased that the FDA has granted Priority Review for daratumumab in double refractory multiple myeloma. If approved, daratumumab has the potential to make a real difference in the lives of people who have run out of other treatment options for multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Approximately 26,850 new patients will be diagnosed with multiple myeloma this year in the US and approximately 11,240 people will die from the disease
Currently, several Phase III clinical studies with daratumumab are ongoing.