FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia
Regulatory approval: On June 14, 2024, the FDA approved blinatumomab (Blincyto) for adults and pediatric patients ≥1 month old with CD19-positive, Philadelphia chromosome–negative B-cell precursor acute lymphoblastic leukemia in the consolidation phase of multiphase chemotherapy. Approval was supported by randomized trials in adults (E1910) and in pediatric/young adult patients (Study 20120215), showing improved overall survival versus chemotherapy-based comparators. The review used Project Orbis and RTOR and received priority review, breakthrough, and orphan designations.
FDA approval: blinatumomab for consolidation in CD19+ Ph− BCP ALL
On June 14, 2024, the FDA granted a regulatory approval for blinatumomab (Blincyto, Amgen) for adult and pediatric patients ≥1 month old with CD19-positive, Philadelphia chromosome–negative B-cell precursor acute lymphoblastic leukemia (Ph− BCP ALL) in the consolidation phase of multiphase chemotherapy.
Supporting efficacy data
Study E1910 (NCT02003222) randomized 112 adults to a consolidation regimen including multiple blinatumomab monotherapy cycles plus intensive chemotherapy vs 112 to intensive chemotherapy alone. Primary endpoint was overall survival (OS). 3-year OS was 84.8% vs 69% (HR 0.42, 95% CI 0.24–0.75; p=0.003). With median follow-up 4.5 years, 5-year OS was 82.4% vs 62.5% (HR 0.44, 95% CI 0.25–0.76).
Study 20120215 (NCT02393859) randomized pediatric and young adult patients to blinatumomab (n=54) vs intensive combination chemotherapy (n=57) as the third consolidation cycle. 5-year OS was 78.4% vs 41.4% (HR 0.35, 95% CI 0.17–0.70); 5-year RFS was 61.1% vs 27.6% (HR 0.38, 95% CI 0.22–0.66).
Safety
Common (≥20%) adverse reactions in E1910 included cytopenias, headache, infection, nausea, diarrhea, musculoskeletal pain, and tremor; in Study 20120215 included pyrexia, nausea, headache, rash, hypogammaglobulinemia, and anemia.
The review used Project Orbis and RTOR; partner agency reviews were ongoing at the time of the FDA announcement.