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European Commission Approves BLINCYTO® for Acute Lymphoblastic Leukemia

The European Commission (EC) has recently granted approval for Amgen’s BLINCYTO® (blinatumomab) as a monotherapy. This drug is specifically indicated for adult patients diagnosed with Philadelphia chromosome-negative CD19-positive acute lymphoblastic leukemia (ALL) during the consolidation phase of treatment. This significant advancement offers potential life-saving benefits to patients, allowing for earlier incorporation of this innovative therapy in their treatment regimens.

In a statement, Jean-Charles Soria, Senior Vice President of Global Oncology Development at Amgen, remarked on this groundbreaking advancement, highlighting the importance of earlier access to BLINCYTO for patients. The approval is supported by data from the pivotal E1910 clinical trial conducted by the ECOG-ACRIN Cancer Research Group, which demonstrated compelling evidence of BLINCYTO’s positive impact on survival rates.

The E1910 Trial

The E1910 Phase 3 clinical trial focused on adult patients with newly diagnosed Philadelphia chromosome-negative ALL. These patients underwent consolidation therapy post-induction, which aims to deepen remission for long-term results. The results unveiled a superior overall survival (OS) rate for patients administered BLINCYTO alongside a multi-phase consolidation chemotherapy regimen, in contrast to those receiving chemotherapy alone.

With a median follow-up of 4.5 years, the five-year OS was reported at 82.4% for the BLINCYTO plus chemotherapy group (112 patients), compared to 62.5% for the chemotherapy-only group (112 patients). Such findings underscore the effectiveness of BLINCYTO in improving patient outcomes in this challenging cancer diagnosis.

Dr. Robin Foà, Professor Emeritus of Hematology at the University of Sapienza in Rome, emphasized that many patients diagnosed with Philadelphia chromosome-negative ALL remain at high risk of relapse, highlighting the need for new treatment options. He noted that the evidence from the E1910 trial supports the role of BLINCYTO in advancing first-line consolidation therapy, offering crucial options for deeper remissions and improved long-term survival rates.

About Acute Lymphoblastic Leukemia (ALL)

Acute lymphoblastic leukemia (ALL) is a rapidly progressing blood cancer that originates in the bone marrow and can metastasize to other areas, including lymph nodes, liver, spleen, and the central nervous system. In Europe, the estimated prevalence of ALL is about 1.28 cases per 100,000 people. The most common subtype of ALL in both children and adults is B-cell precursor ALL, accounting for approximately 75% of adult cases.

Understanding BLINCYTO®

BLINCYTO is recognized as the world’s first bispecific T-cell engager (BiTE®) therapy approved for clinical use. It works by targeting the CD19 antigen on B cells, assisting the immune system in identifying and attacking malignant cells. By bringing T cells, a type of white blood cell that can kill other cells deemed as threats, in closer contact with cancer cells, BLINCYTO effectively triggers the destruction of these diseased cells through apoptosis.

Currently, BLINCYTO holds EU indications for:

• - Adults with recurrent or refractory CD19-positive B-cell precursor ALL, Philadelphia chromosome-negative.
• - Patients in first or second complete remission with minimal residual disease of 0.1% or more.
• - Pediatric patients aged one month and older with CD19-positive B-cell precursor ALL, refractory or relapsed after at least two prior therapies.
• - Pediatric patients with first high-risk relapse of CD19-positive, Philadelphia chromosome-negative B-cell precursor ALL, during consolidation treatment.

Moreover, BLINCYTO has earned the designation of breakthrough therapy and priority review from the U.S. FDA, reflecting its significant potential to change the treatment landscape for patients fighting this aggressive form of leukemia.

Conclusion

The approval of BLINCYTO as a viable treatment option by the European Commission marks a vital step forward in addressing unmet needs within the oncology space, particularly in the domain of acute lymphoblastic leukemia. As research progresses, patients stand to benefit from advanced therapeutic options tailored to elevate survival outcomes and enhance quality of life during their treatment journey.

Amgen remains committed to innovating and delivering effective therapies to meet the challenges posed by severe illnesses, thus reaffirming its leadership in the biopharmaceutical landscape.