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European Commission Grants Approval for BLINCYTO®

Amgen, a biotech innovator based in Thousand Oaks, California, has made a noteworthy announcement regarding the approval of their drug BLINCYTO® (blinatumomab) by the European Commission (EC). This significant milestone marks the drug's use in adult patients diagnosed with newly identified acute lymphoblastic leukemia (B-ALL) that is Philadelphia chromosome-negative and CD19-positive during the consolidation phase of treatment.

This approval is rooted in the outcomes derived from the E1910 clinical trial, where BLINCYTO, administered alongside a multi-phase chemotherapy regimen, demonstrated a marked reduction in mortality risk compared to chemotherapy alone. Efficacy results indicate that this combination therapy not only enhances overall survival rates but also offers a promising alternative to conventional treatments.

In the E1910 study, led by the ECOG-ACRIN cancer research group, patients subjected to this multi-phase consolidation treatment displayed substantial improvements in overall survival (OS). The study revealed a five-year OS of 82.4% in the group receiving the combination of BLINCYTO and chemotherapy, in contrast to 62.5% for those treated with chemotherapy alone—at a median follow-up period of 4.5 years.

Jean-Charles Soria, Senior Vice President of Global Oncology Research at Amgen, emphasized the significance of this achievement. He stated, "This approval represents significant progress, providing patients the opportunity to receive BLINCYTO earlier in the treatment process, with the potential to improve outcomes."

Despite strides made in treatment, many patients currently diagnosed with Philadelphia chromosome-negative B-ALL face high relapse risks. Moreover, Robin Foà, an Emeritus Professor of Hematology at Sapienza University in Rome, highlighted that the E1910 results underscore BLINCYTO's potential to advance primary consolidation treatment, even for patients with minimal residual disease (MRD).

BLINCYTO marks a breakthrough as the first globally approved bispecific T-cell engager (BiTE®) immunotherapy aimed at treating B-ALL by targeting CD19 antigens on B-cells. By directing T-cells—white blood cells responsible for combating perceived threats—toward the cancer cells, this innovative approach augments the immune system's ability to identify and eliminate malignant cells effectively.

About Acute Lymphoblastic Leukemia (ALL)

Acute lymphoblastic leukemia (ALL) is a fast-developing blood cancer originating in the bone marrow. It has the potential to invade other body parts, including lymph nodes and the central nervous system. An estimated 1.28 cases per 100,000 individuals are diagnosed with ALL annually in Europe, with B-ALL being the most prevalent subtype across both adults and children.

Future Implications

The approval in the European Union allows BLINCYTO to be administered as a standalone treatment for specific patient groups, including adults undergoing consolidation therapy for newly diagnosed B-ALL. Meanwhile, in the United States, the FDA has granted breakthrough designation for BLINCYTO, reflecting its significant potential in the ongoing battle against B-ALL.

As Amgen continues to innovate within the oncology landscape, efforts will persist to explore the full potential of BiTE® technology, which is currently under investigation for various types of malignancies. This highlights a robust commitment to not only enhancing treatment efficacy but also improving the overall patient experience in their fight against formidable diseases.

For further information about Amgen's initiatives and their ongoing research, you can visit Amgen's official website. Amgen maintains a presence on various social media platforms, including X, LinkedIn, and Instagram, to keep the public informed on their latest achievements and developments.