Blincyto Approved for Patients with B-Cell ALL and Minimal Residual Disease

May 2018, Vol 8, No 5 - FDA Approvals, News & Updates


On March 29, 2018, the FDA accelerated the approval of a new indication for blinatumomab (Blincyto; 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 because of minimal residual disease (MRD). The FDA granted blinatumomab orphan drug status for this indication.

Blinatumomab was originally approved for patients with Philadelphia chromosome 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.

The approval of this new indication was based on a single-arm study with 86 patients whose ALL was in complete remission but had detectable MRD. Blinatumomab efficacy was based on patients reaching undetectable MRD status after 1 treatment cycle, as determined by an assay, as well as on survival duration or remission. Of the 86 patients in this study, 70 had undetectable MRD with blinatumomab, and more than 50% remained alive and in remission by ≥22.3 months.

The common side effects associated with blinatumomab include bacterial and pathogen-unspecified infections, pyrexia, headache, infusion-related reactions, neutropenia, anemia, febrile neutropenia, and thrombocytopenia.