FDA Approves BLINCYTO® for CD19-Positive Philadelphia Chromosome-Negative B-ALL in Consolidation Phase

Amgen has secured U.S. FDA approval for BLINCYTO® (blinatumomab) as a treatment for adult and pediatric patients, aged one month and older, with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, irrespective of measurable residual disease (MRD) status. This move marks a significant advance in treating this aggressive blood cancer, broadening the reach of BLINCYTO to more patients at a critical stage of treatment.

BLINCYTO, developed by Amgen, is a bispecific T-cell engager (BiTE®) therapy, the first of its kind for consolidation treatment regardless of MRD status. It functions by linking T cells to cancer cells, enabling the immune system to target and eliminate malignant cells. The approval is based on the results from the Phase 3 E1910 trial conducted by ECOG-ACRIN Cancer Research Group, which demonstrated that BLINCYTO, when added to multiphase consolidation chemotherapy, significantly improved overall survival rates compared to chemotherapy alone.

Key findings from the E1910 study revealed a 3-year overall survival rate of 84.8% in the BLINCYTO plus chemotherapy group versus 69% for those receiving only chemotherapy. A follow-up over a median of 4.5 years showed a 5-year overall survival rate of 82.4% for the BLINCYTO group compared to 62.5% for the chemotherapy group.

Dr. Jay Bradner, Executive Vice President of Research and Development at Amgen, emphasized the importance of this approval, noting that "BLINCYTO has already been transformative for many patients over the past decade, and this new indication allows us to reach even more individuals in need." The drug's efficacy in reducing the risk of death and enhancing overall survival marks a potential shift in the standard of care for B-ALL patients.

Dr. Selina M. Luger, a professor at the University of Pennsylvania and part of the ECOG-ACRIN Leukemia Committee, highlighted that the E1910 study showcased BLINCYTO's ability to significantly lower mortality risk, offering a promising alternative to traditional chemotherapy. Similarly, Dr. E. Anders Kolb, CEO of The Leukemia & Lymphoma Society, noted the relevance of this approval for the B-ALL patient community, given the high risk of recurrence after initial treatment phases.

The E1910 study, independent of industry influence, was sponsored by ECOG-ACRIN with public funding from the National Cancer Institute (NCI). Amgen supported the trial by providing BLINCYTO under an NCI Cooperative Research and Development Agreement.

Acute lymphoblastic leukemia (ALL) is a rapidly progressing cancer affecting the bone marrow and can spread to other organs. It is relatively rare, with an estimated 6,540 new cases in the U.S. in 2023. B-ALL, a subset of ALL, begins in immature cells intended to develop into B-cell lymphocytes. It remains the most common form of ALL, accounting for about 75% of adult cases.

BLINCYTO's approval history includes prior designations as a breakthrough therapy and Priority Review by the FDA. It is authorized for various indications in both the U.S. and European Union, including treatment for relapsed or refractory B-ALL and MRD-positive B-ALL in different patient demographics.

Despite its benefits, BLINCYTO therapy comes with significant safety considerations, including risks of cytokine release syndrome (CRS) and neurological toxicities such as immune effector cell-associated neurotoxicity syndrome (ICANS). These conditions can be severe, underscoring the need for careful patient monitoring and management during treatment.

BLINCYTO's introduction into the standard care for B-ALL patients represents a meaningful advancement, offering a new option that improves survival outcomes and addresses an unmet need in oncology treatment.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!