FDA approves Amgen’s BLINCYTO for expanded use in B-ALL treatment

Amgen (NASDAQ: AMGN) has achieved a significant milestone with the recent U.S. Food and Drug Administration (FDA) approval of BLINCYTO (blinatumomab) for the consolidation phase treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL), irrespective of measurable residual disease (MRD) status.

Key Study Findings and Approval Details

This approval, which marks the third indication for BLINCYTO, stems from the compelling results of the Phase 3 E1910 clinical trial led by the ECOG-ACRIN Cancer Research Group. The study demonstrated that BLINCYTO combined with multiphase consolidation chemotherapy significantly improves overall survival (OS) rates compared to chemotherapy alone. Specifically, the 3-year OS rate was 84.8% in the BLINCYTO plus chemotherapy group versus 69% in the chemotherapy group, with a hazard ratio of 0.42 indicating a 58% reduction in the risk of death.

Amgen’s BLINCYTO receives FDA approval for expanded use in B-ALL, significantly improving survival rates.

A New Standard in B-ALL Care

Jay Bradner, M.D., Executive Vice President, Research and Development, and Chief Scientific Officer at Amgen, emphasized the transformative potential of this first-in-class Bispecific T-cell Engager (BiTE) therapy: “Today’s approval in the frontline consolidation phase, regardless of MRD status, allows us to reach more patients than ever with this transformative therapy.” Selina M. Luger, M.D., Professor of Hematology-Oncology at the University of Pennsylvania’s Perelman School of Medicine and an investigator in the study, noted, “This approval redefines the standard of care for patients with B-ALL and provides them with a more effective treatment option than standard chemotherapy alone.”

Impact on Patient Outcomes and Clinical Practice

The study’s 5-year follow-up data further underscored BLINCYTO’s efficacy, revealing a 5-year OS of 82.4% in the BLINCYTO group compared to 62.5% in the chemotherapy group. Additionally, a significantly higher complete response rate was observed in the BLINCYTO group. E. Anders Kolb, M.D., President and CEO of The Leukemia & Lymphoma Society, highlighted the critical nature of these advancements: “B-ALL is the most common type of ALL, and having another effective option available earlier in a patient’s treatment journey is critical for clinicians who are working to give these patients more time with their loved ones.”

BiTE Mechanism and Broader Implications

BLINCYTO, the first globally approved BiTE immuno-oncology therapy, targets CD19 surface antigens on B cells, engaging T cells to induce apoptosis in cancer cells. This innovative mechanism has positioned BLINCYTO at the forefront of treatments not just for B-ALL but potentially for a broad spectrum of other cancers.

Regulatory and Research Advancements

With prior breakthrough therapy and Priority Review designations, BLINCYTO’s latest approval further expands its use in the U.S. and aligns with its indications in the European Union for various B-ALL conditions. The E1910 study was notably sponsored by ECOG-ACRIN with public funding from the National Cancer Institute, highlighting its independence from industry influence.

Amgen’s BLINCYTO now sets a new benchmark in the treatment of B-ALL, offering hope and enhanced outcomes for patients facing this aggressive cancer type. This approval not only reflects a significant leap in leukemia care but also exemplifies the potential for targeted therapies to transform cancer treatment paradigms.