Janssen Research & Development, LLC (Janssen) announced today the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for daratumumab as a treatment for patients with multiple myeloma who are refractory to both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who have received three or more prior lines of therapy, including a PI and an IMiD. This is referred to as "double refractory" multiple myeloma, which occurs when a patient's disease has become resistant to at least two of the most commonly utilized and active classes of anti-myeloma agents.
The FDA grants Priority Review to investigational therapies that if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.[1] This designation shortens the review period to six months compared to 10 months for Standard Review. With today’s announcement, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016 to render a decision on the daratumumab application.
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells. Multiple myeloma is the third most common blood cancer in the U.S., behind only leukemia and lymphoma.[3] Approximately 26,850 new patients will be diagnosed with multiple myeloma, and approximately 11,240 people will die from the disease in the U.S. in 2015. Globally, it is estimated that 124,225 people will be diagnosed and 87,084 will die from the disease in 2015. While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections. Patients who relapse after treatment with standard therapies, including PIs or IMiDs, have poor prognoses and few treatment options.
