The agency previously approved the drug for patients with acute lymphoblastic leukemia who did not respond to previous treatment or whose cancer returned after treatment.
The most recent approval expands the drug’s access to patients with “minimal residual disease,” or a small presence of cancer cells that can’t be seen under a microscope. Clinicians use molecular testing to identify these patients, who are at a greater risk for readmission.
“Until today, no therapy has been satisfactory in eradicating [minimal residual disease] or approved specifically to treat this high-risk patient population,” said David M. Reese, MD, Amgen’s senior vice president of translational sciences and oncology. “This approval not only supports the use of Blincyto earlier in the ALL treatment continuum, but represents a paradigm shift in the management of ALL.”
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