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European Commission Approves BLINCYTO for Philadelphia Chromosome-Negative B-ALL

Amgen (NASDAQ: AMGN) has announced a significant milestone in cancer treatment as the European Commission has granted approval for BLINCYTO® (blinatumomab), allowing it to be used as a monotherapy for adults suffering from newly diagnosed Philadelphia chromosome-negative CD19-positive B-precursor acute lymphoblastic leukemia (B-ALL) during the consolidation phase of treatment.

This approval can be seen as a groundbreaking advancement for patients battling this aggressive form of leukemia. Jean-Charles Soria, the Senior Vice President of Global Oncology Development at Amgen, highlighted the potential of BLINCYTO to enhance treatment outcomes for these patients, stating, "This approval signifies a major step forward and allows patients to utilize BLINCYTO at an earlier stage of treatment with the potential for improved results."

Clinical Trial Insights

The approval is based on findings from the E1910 clinical trial, overseen by the ECOG-ACRIN Cancer Research Group. This third-phase trial focused on individuals with newly diagnosed Philadelphia chromosome-negative B-ALL who underwent post-induction consolidation therapy. The objective was to deepen remission and achieve a lasting response. Results indicated that the combination of BLINCYTO with multi-phase consolidation chemotherapy significantly improved overall survival rates compared to chemotherapy alone. After a median follow-up of 4.5 years, the five-year overall survival rate for the group receiving both BLINCYTO and chemotherapy was 82.4%, compared to 62.5% for those receiving only chemotherapy.

Despite advances in treatment, many patients with newly diagnosed Philadelphia chromosome-negative B-ALL remain at a high risk of relapse. Dr. Robin Foà, an emeritus professor of hematology at Sapienza University in Rome, noted that the findings from the E1910 study underscore the potential of BLINCYTO to advance primary consolidation therapy, even for patients negative for minimal residual disease (MRD-negative). This creates a vital new opportunity for achieving deeper remission and enhancing long-term survival chances.

Understanding Acute Lymphoblastic Leukemia (ALL)

Acute lymphoblastic leukemia (ALL) is a fast-acting blood cancer that begins in the bone marrow and can spread to other areas, including lymph nodes, liver, spleen, and central nervous system. In Europe, the incidence of ALL is estimated at 1.28 per 100,000 individuals. B-precursor ALL, which arises from immature cells that should normally develop into B-lymphocytes (a type of white blood cell), is the most common subtype of ALL and accounts for more than 75% of adult cases.

About BLINCYTO® (blinatumomab)

BLINCYTO is the world's first FDA-approved immuno-oncological treatment utilizing bispecific antibodies designed to target CD19 surface antigens on B-cells. These bispecific T-cell engagers (BiTEs) function by guiding the immune system to identify and attack cancerous cells, effectively linking T-lymphocytes to those malignant cells to trigger their elimination through apoptosis. Currently, research is ongoing to explore the potential of BiTE immuno-oncological therapy for various cancer types.

In the European Union, BLINCYTO is indicated as monotherapy for treating adults with Philadelphia chromosome-negative CD19-positive relapsed or refractory B-ALL. It has gained approval in the United States for multiple patient age groups under similar conditions and has been assigned Breakthrough Therapy designation by the FDA.

Safety Profile and Future Directions

According to the E1910 study, BLINCYTO presents a safety profile consistent with its established clinical history, indicating its viability for patient use. Amgen is committed to furthering its research and development endeavors in the immuno-oncology space, focusing on improving patient outcomes. The success of BLINCYTO heralds a new era of targeted treatments for B-ALL and similar malignancies, potentially transforming care for individuals grappling with these challenging conditions.

For more information, visit Amgen's website and follow them on various social media platforms to stay updated on this and future advancements in oncology.