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European Commission Approves BLINCYTO®

Amgen has announced that the European Commission (EC) has granted approval for BLINCYTO® (blinatumomab) to be utilized as a monotherapy in consolidation therapy for patients with a specific type of acute lymphoblastic leukemia (ALL). This approval is particularly focused on patients with Philadelphia chromosome-negative, CD19-positive precursor B-cell ALL, which has been recently diagnosed. This marks a significant milestone as it enables patients to benefit from BLINCYTO earlier in their treatment journey, which could potentially lead to better clinical outcomes.

Significant Findings from Clinical Studies

Jean-Charles Soria, Amgen’s Senior Vice President of Global Oncology Development, emphasized that this development presents a substantial opportunity for patients. With reference to the E1910 clinical trial, he highlighted the critical evidence supporting the impact of BLINCYTO on patient survival rates. The E1910 trial was a phase 3 clinical study focused on patients who had recently been diagnosed with Philadelphia chromosome-negative B-cell ALL, assessing the effectiveness of BLINCYTO alongside multi-phase consolidation chemotherapy.

The results indicated that the addition of BLINCYTO led to significantly higher overall survival rates compared to chemotherapy alone. In the cohort receiving both BLINCYTO and chemotherapy (112 patients), the five-year survival rate was noted at 82.4%, compared to 62.5% in the chemotherapy-only group.

Experts Weigh In

Dr. Robin Foà, an eminent hematology professor from La Sapienza University in Rome, remarked that while advancements in treatment have been made, many patients diagnosed with Philadelphia chromosome-negative B-cell ALL are still at a high risk for relapse. He noted that the findings from the E1910 study underscore BLINCYTO’s potential to enhance frontline consolidation therapy, even for patients without minimal residual disease (MRD). This development could provide a crucial new option for achieving deeper remissions and improving long-term survival rates.

The E1910 study was independently designed and executed, primarily funded by public sources, while Amgen provided BLINCYTO and additional support through a Cooperative Research and Development Agreement.

Understanding Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) is a rapidly progressing blood cancer that typically originates in the bone marrow and can spread to other areas such as lymph nodes and the central nervous system. In Europe, ALL is estimated to affect 1.28 individuals per 100,000 inhabitants, with B-ALL being the most common subtype among both adults and children, accounting for approximately 75% of adult cases.

About BLINCYTO® and Its Mechanism of Action

BLINCYTO is recognized as the first globally approved immuno-oncology BiTE® (Bispecific T-cell Engager) therapy targeting the CD19 surface antigens on B cells. The BiTE® technology functions to harness the patient’s immune system by bridging T-cells—immune cells capable of eliminating perceived threats—with cancer cells, leading to targeted destruction of malignancies. The efficacy of BiTE® therapies is under investigation for various cancer types beyond ALL.

In the EU, BLINCYTO is indicated for adults experiencing relapsed or refractory Philadelphia chromosome-negative B-ALL, as well as for pediatric patients starting from one month of age. It has also demonstrated efficacy in various stages of the illness, emphasizing its versatility and potential across patient demographics.

Conclusion

The approval of BLINCYTO is seen as a revolutionary step in treating acute lymphoblastic leukemia, providing patients access to advanced therapy at a critical early treatment stage. Amgen's ongoing commitment to research and development in oncology continues to yield promising outcomes that can meaningfully enhance the quality of care for patients facing severe diseases.

For more information regarding BLINCYTO and associated clinical data, visiting Amgen’s official websites and relevant medical literature is advised.