#None #Amgen #BLINCYTO #Acute Lymphoblastic Leukemia #Thousand Oaks, California

European Commission Approves BLINCYTO® for Acute Lymphoblastic Leukemia Treatment

On January 30, 2025, Amgen (NASDAQ: AMGN) announced a major milestone in cancer treatment with the European Commission's approval of BLINCYTO® (blinatumomab) for adult patients diagnosed with Philadelphia chromosome-negative, CD19-positive acute lymphoblastic leukemia (B-ALL). This approval allows BLINCYTO to be used as a standalone therapy in the consolidation phase, marking a significant development in the treatment landscape for this aggressive blood cancer.

The Significance of BLINCYTO®

BLINCYTO® is a novel immunotherapy that utilizes the BiTE® (Bispecific T-Cell Engager) technology, engaging the patient’s own T-cells to target and destroy B-cells that express the CD19 antigen. This mechanism supports the immune system in combating leukemia cells more effectively. Jean-Charles Soria, Senior Vice President of International Oncology Development at Amgen, emphasized that this approval presents patients with an opportunity for earlier treatment, potentially leading to improved outcomes.

Recent studies, particularly Phase 3 E1910 trial results, underpin the efficacy of BLINCYTO when combined with multi-agent chemotherapy. This research showed a heightened overall survival rate of 82.4% at five years for patients receiving BLINCYTO alongside chemotherapy compared to 62.5% for those receiving chemotherapy alone.

Clinical Insights and Prospects

Dr. Robin Foà, an esteemed hematologist from Sapienza University in Rome, highlighted the pressing need for innovative therapies as many patients diagnosed with B-ALL without the Philadelphia chromosome remain at a significant risk for relapse. The findings from the E1910 study demonstrate BLINCYTO's potential to develop deeper remissions, offering a critical option for patients who may not respond adequately to current treatments.

The E1910 study, independently conducted by ECOG-ACRIN Cancer Research Group with funding from the National Cancer Institute (NCI), evaluated patients who had previously been treated but required consolidation therapy to maintain remission and achieve a durable response. BLINCYTO was assessed against standard chemotherapy, affirming its role in enhancing survival rates in this patient population.

Overview of Acute Lymphoblastic Leukemia (B-ALL)

Acute lymphoblastic leukemia is a rapid-growing blood cancer originating in the bone marrow, often spreading to adjacent organs. B-ALL represents the most common form of ALL in adults, accounting for about 75% of cases. In Europe, an estimated incidence of B-ALL is approximately 1.28 per 100,000 people, signifying its prevalence and the urgent need for effective treatments like BLINCYTO.

The latest European approval for BLINCYTO follows its initial successes in treating patients resistant to or relapsed after prior therapies, extending its indication to newly diagnosed B-ALL patients as well. This flexibility in treatment options promises to enhance survival rates and the quality of life for patients affected by this life-threatening condition.

Conclusion

Amgen's commitment to investigating and expanding the applications of BLINCYTO underscores its pivotal role in the future of oncology. As healthcare continues to evolve, the introduction of innovative therapies like BLINCYTO not only signifies a breakthrough for cancer treatment but also brings hope for many patients battling acute lymphoblastic leukemia globally. Detailed information regarding BLINCYTO can be found on the European Medicines Agency website.

For more updates, follow Amgen’s progress and innovations across their social media channels, including LinkedIn, Instagram, and YouTube.