On March 29, 2018, the FDA approved a new indication for Blincyto (blinatumomab; from Amgen) for the treatment of patients with B-cell precursor acute lymphoblastic leukemia (ALL) whose disease was in remission but was at risk for relapse (returning) because of minimal residual disease (MRD). This is the first time the FDA has used MRD as a biomarker to approve a specific treatment for patients with ALL. Blincyto was initially approved for patients with the Philadelphia chromosome and relapsed or refractory B-cell precursor ALL.
“This is the first FDA-approved treatment for patients with MRD-positive ALL. Because patients who have MRD are more likely to relapse, having a treatment option that eliminates even very low amounts of residual leukemia cells may help keep the cancer in remission longer,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.
In the clinical trial that led to this approval, of the 86 patients in this study, 70 had undetectable MRD with Blincyto, and more than half remained alive and in remission for 22.3 months or longer.
The common side effects associated with Blincyto include infections, fever, headache, infusion-related reactions, neutropenia, anemia, febrile neutropenia, and thrombocytopenia.
