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The US Food and Drug Administration approved blinatumomab (Blincyto — Amgen) as consolidation for CD19-positive, Philadelphia chromosome–negative B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in both children and adults.

Originally approved in 2014, the bispecific CD19-directed CD3 T-cell engager (BiTE) carries additional CD19-positive BCP-ALL indications for relapsed or refractory disease and disease in the first or second complete remission with measurable residual disease (MRD) of ≥ 0.1%.

The new indication makes blinatumomab the only BiTE for consolidation treatment regardless of MRD status, Amgen said in a press release.

Efficacy was evaluated in two trials. Following induction and intensification of chemotherapy in the first trial, Study E1910, 224 adults in complete remission were randomized equally to consolidation with intensive chemotherapy alone or in combination with blinatumomab.

Three-year overall survival (OS) was 84.8% in the blinatumomab group vs 69% with chemotherapy alone. Five-year OS was 82.4% with blinatumomab vs 62.5%.

In the Amgen press release, investigator Selina Luger, MD, a leukemia specialist at the University of Pennsylvania, Philadelphia, called the OS improvement "remarkable" and said the new approval of blinatumomab "redefines the standard of care for patients with B-ALL."

In the second trial, Study 20120215, 54 children and young adults were randomized to blinatumomab and 57 to intensive combination chemotherapy for the third cycle of consolidation.

Five‑year OS was 78.4% with blinatumomab vs 41.4% with chemotherapy. Five-year relapse-free survival was 61.1% in the blinatumomab group vs 27.6%. In the E1910 study, ≥ 20% of blinatumomab subjects developed neutropenia, thrombocytopenia, anemia, leukopenia, headache, infection, nausea, lymphopenia, diarrhea, musculoskeletal pain, and tremor. In Study 20120215, ≥ 20% of blinatumomab patients developed pyrexia, nausea, headache, rash, hypogammaglobulinemia, and anemia.

The agent carries a black box warning of cytokine release syndrome and neurological toxicities, including immune effector cell–associated neurotoxicity syndrome. A single 35 mcg dose of blinatumomab costs approximately $5427, according to drugs.com.

M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com.