FDA Approves Blincyto (Blinatumomab) for Consolidation Therapy in CD19-Positive, Philadelphia Chromosome-Negative B-ALL Regardless of MRD Status

Jul 02, 2024 21:30 CST Updated 21:30

Amgen

Developer of Treatment Drugs for Serious Diseases

On June 14, 2024, the U.S. FDA approvedAmgenBispecific Antibody TherapyBlincyto（blinatumomab）For the treatment of one month or longer, CD19 positive, Philadelphia chromosome negativePatients with B-cell precursor acute lymphoblastic leukemia (B-ALL)The consolidation phase of treatment.

◉Blincyto is the first and only bispecific T-cell engager (BiTE®) therapy for consolidation treatment.

◉ Regardless of the patient's measurable residual disease (MRD) status.

◉ Blincyto Combined with Multi-Phase Consolidation Chemotherapy Reduces Risk of Death by 58%.

Blincyto Key Studies

This approval is based onE1910 Phase 3 Clinical TrialThe results. The trial investigated the effects of consolidation therapy after induction in newly diagnosed Philadelphia chromosome-negative B-ALL patients, aiming to deepen remission for durable responses.

In the E1910 study, the Blincyto treatment groupThe 3-year overall survival rate (OS) is 84.8%.(95%CI，76.3%-90.4%)，The chemotherapy group was 69%.(95%CI，58.7%-77.2%)(HR，0.42;95%CI，0.24-0.75;P=.003)。

The median follow-up time was 4.5 years, and the Blincyto treatment group's 5-yearOS rate was 82.4%(95%CI，73.7%-88.4%)，Whereas the chemotherapy group was 62.5%(95%CI，52.0%-71.3%;HR，0.44;95%CI，0.25-0.76)。

Blincyto（blinatumomab）

Blincyto is the world's first approved BiTE immunotherapy targeting the B-cell CD19 surface antigen.BiTE molecules help the body's immune system detect and target malignant cells to fight cancer by binding T cells (a type of white blood cell capable of killing other cells perceived as threats) with cancer cells. By bringing T cells close to cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis).

Blincyto Granted Breakthrough Therapy and Priority Review Designations by U.S. FDA

December 2014The U.S. FDA has approved Blincyto for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory (R/R) precursor B-cell acute lymphoblastic leukemia (pre-B ALL).

May 2022, approved for the treatment of pediatric patients with relapsed or refractory (R/R) CD19-positive precursor B-cell acute lymphoblastic leukemia.

June 2024, approved for the consolidation treatment of patients one month or older with CD19-positive, Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL), regardless of measurable residual disease (MRD) status. This is the third approved indication for Blincyto.

Acute Lymphoblastic Leukemia (ALL)

Acute lymphoblastic leukemia is a rapidly progressing blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, includingLymph nodes, liver, spleen, and central nervous system。

Acute Lymphoblastic Leukemia (ALL) is a rare disease, with 6,540 new cases diagnosed in the United States in 2023, affecting both children and adults. B-cell Acute Lymphoblastic Leukemia (B-ALL) originates from immature cells that typically develop into B lymphocytes, a type of white blood cell that grows in the bone marrow. B-ALL is the most common type of ALL, accounting for approximately 75% of adult cases.

Reference Source:

[1]https://wwwext.amgen.com/newsroom/press-releases/2024/06/fda-approves-blincyto-blinatumomab-in-cd19positive-philadelphia-chromosomenegative-bcell-precursor-acute-lymphoblastic-leukemia-ball-in-the-consolidation-phase

[2]https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-blinatumomab-consolidation-cd19-positive-philadelphia-chromosome-negative-b-cell

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