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  6. FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia
  1. Resources for Information | Approved Drugs

FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia

On June 14, 2024, the Food and Drug Administration approved blinatumomab (Blincyto, Amgen Inc.) for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph-negative BCP ALL) in the consolidation phase of multiphase chemotherapy.

Full prescribing information for Blincyto will be posted on Drugs@FDA.

Efficacy and Safety

Efficacy was evaluated in Study E1910 (NCT02003222), a randomized, controlled trial in adult patients with newly diagnosed Ph-negative BCP ALL. Eligible patients in hematologic complete remission (CR) or CR with incomplete peripheral blood count recovery (CRi) following induction and intensification chemotherapy were randomized 1:1 to receive a consolidation regimen comprised of multiple blinatumomab monotherapy cycles plus multiple cycles of intensive chemotherapy (blinatumomab arm) or to intensive chemotherapy alone (chemotherapy arm). Randomization was stratified by age, CD20 status, rituximab use, and intent to undergo allogeneic hematopoietic stem cell transplantation (HSCT). There were 112 patients randomized to the blinatumomab arm and 112 to the chemotherapy arm.

The major efficacy outcome measure was overall survival (OS). The 3-year OS was 84.8% (95% CI: 76.3, 90.4) and 69% (95% CI: 58.7, 77.2) in the blinatumomab and chemotherapy arms, respectively. The hazard ratio [HR] for OS was 0.42 [95% CI: 0.24, 0.75] p-value 0.003). In a later analysis with a median follow-up of 4.5 years, the 5-year OS was 82.4 % [95% CI (73.7, 88.4)] in the blinatumomab arm and 62.5 % [95% CI (52.0, 71.3)] in the chemotherapy arm. The hazard ratio was 0.44 [95% CI (0.25, 0.76)].

Efficacy also was evaluated in Study 20120215 (NCT02393859), a randomized, controlled, open-label, multicenter trial. Pediatric and young adult patients with Ph-negative BCP ALL were randomized 1:1 to receive blinatumomab or the IntReALLHR2010 HC3 intensive combination chemotherapy as the third consolidation cycle. Randomization was stratified by age, minimal residual disease status at the end of induction based on local assessment, and bone marrow status at the end of the second block of consolidation chemotherapy. There were 54 patients randomized to the blinatumomab arm and 57 to the chemotherapy arm.

The major efficacy outcome measures were OS and relapse-free survival (RFS). The 5‑year OS was 78.4% (95% CI: 64.2, 87.4) and 41.4% (95% CI: 26.3, 55.9) in the blinatumomab and chemotherapy arms, respectively (OS HR 0.35 [95% CI: 0.17, 0.70]). The 5-year RFS was 61.1% (95% CI: 46.3, 72.9) and 27.6% (95% CI: 16.2, 40.3) in the blinatumomab and chemotherapy arms, respectively (RFS HR 0.38 [95% CI: 0.22, 0.66].

In Study E1910, the most common adverse reactions (≥20%) in the blinatumomab arm were neutropenia, thrombocytopenia, anemia, leukopenia, headache, infection, nausea, lymphopenia, diarrhea, musculoskeletal pain, and tremor. In Study 20120215, the most common adverse reactions (≥20%) in the blinatumomab arm were pyrexia, nausea, headache, rash, hypogammaglobulinemia, and anemia.

See the full prescribing information for the recommended dose by patient weight and schedule.

Expedited Programs

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Brazilian Health Regulatory Agency (ANVISA), Health Canada (HC), Switzerland’s Swissmedic (SMC), and United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The application reviews are ongoing at the other regulatory agencies.

This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review, breakthrough designation, and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X @FDAOncology

 
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