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FDA Grants Expanded Approval for Treatment of ALL
The FDA has granted expanded approval for a drug to treat adults and children with acute lymphoblastic leukemia (ALL).
Blinatumomab (Blincyto; Amgen) is now approved to treat adults and children with B-cell precursor ALL (B-cell ALL) who are in remission but still have minimal residual disease (MRD).
The FDA first approved blinatumomab under accelerated approval in December 2014 for the treatment of Philadelphia chromosome (Ph)-negative relapsed or refractory positive B-cell ALL. Full approval for this indication was granted in July 2017, at which time the indication was also expanded to include patients with Philadelphia chromosome-positive ALL.
The most recent approval is based on results from a single-arm clinical trial that included 86 patients in first or second complete remission who had detectable MRD in at least one out of 1,000 cells in their bone marrow. Efficacy was based on achievement of undetectable MRD in an assay that could detect at least one cancer cell in 10,000 cells after one cycle of blinatumomab treatment, in addition to the length of time that the patients remained alive and in remission.
“This is the first FDA-approved treatment for patients with MRD-positive ALL,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release (March 29, 2018). “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.”—Janelle Bradley
