According to a story from the biotechnology company Amgen, a review from the European Medicines Agency (EMA) has recommended that the indication for blinatumomab, marketed as BLINCYTO®, be expanded. The drug was previously approved as a treatment for patients with Philadelphia chromosome negative acute lymphoblastic leukemia that was refractory or relapsed. Now, its indication has expanded to patients whose disease is in remission but whose minimal residual disease (MRD) is 0.1 percent or higher. Amgen is committed to the development of therapies for serious, life-threatening illnesses.
About Acute Lymphoblastic Leukemia
Acute lymphocytic leukemia, also known as acute lymphoblastic leukemia, is a type of blood cancer. The cells affected by this type of cancer are called lymphocytes, which are a form of white blood cell. This cancer is usually caused when a lymphocytes attains several mutations that affect the development of these blood cells. A number of different genetic mutations have been linked to the disease, but only when several appear at once does the risk for this cancer begin to rise. Other risk factors include radiation, certain types of chemotherapy, and a high birth weight. Symptoms of acute lymphocytic leukemia include weakness, fatigue, bone and joint pain, heavy bruising, anemia, loss of weight and appetite, swelling in the legs and abdomen, and testicular enlargement. Treatment may include chemo, radiation, biological therapy, and immunotherapy. Five year survival rate is poor for adults at just 35 percent. To learn more about acute lymphocytic leukemia, click here.
The Importance of Minimal Residual Disease in Cancer Treatment
The new recommendation is based on information from a Phase II study which was the largest study of patients with MRD-positive acute lymphoblastic leukemia that has been conducted so far. MRD refers to the limited number of cancer cells that may still survive after a patient is received treatment and is in clinical remission from their disease. Measuring MRD requires highly sensitive detection techniques, but the presence of surviving cancer cells has been linked to cancer relapse. The role of MRD in disease recurrence has made it an important indicator of disease and managing it has become a valuable aspect of treatment.
In the Phase II study, blinatumomab was able to eliminate MRD in 78 percent of patients.