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FDA Approves Amgen’s Blincyto to Treat CD19-Positive Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia


The approval of Blincyto was based on results from the Phase III E1910 clinical trial, which found that the treatment significantly improved overall survival in CD19-positive, Ph-negative B-cell ALL compared to chemotherapy alone.

3d rendered medically accurate illustration of leucocytes attacking a cancer cell.

Image Credit: Adobe Stock Images/Sebastian Kaulitzki

The FDA has approved Amgen’s Blincyto (blinatumomab) for the treatment of CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase for patients over one month of age. According to the company, a patient’s measurable residual disease (MRD) status will not affect treatment with Blincyto. The treatment, which was approved based on results from the Phase III E1910 clinical trial, was found to greatly improve overall survival (OS) when used in combination with multiphase consolidation chemotherapy.1

"B-ALL is an aggressive blood cancer with enduring high unmet need. Blincyto has helped thousands of patients with B-ALL over the last 10 years. Today's approval in the frontline consolidation phase, regardless of MRD status, allows us to reach more patients than ever with this transformative, first-in-class Bispecific T-cell Engager (BiTE) therapy," said Jay Bradner, MD, EVP, research and development, chief scientific officer Amgen, in a press release.

E1910 was a randomized clinical trial that evaluated Blincyto combined chemotherapy to compare its effectiveness as a treatment versus induction chemotherapy. The trial enrolled 488 patients to determine whether the combination deepened remission to achieve durable responses. After remission reduction, patients who were in morphologic complete remission continued the study. These patients were randomly assigned to receive an additional four cycles of consolidation chemotherapy or two cycles of Blincyto for 28 days each cycle followed by three cycles of consolidation chemotherapy, another four-week cycle of Blincyto, followed by an additional cycle of chemotherapy and then a fourth cycle of Blincyto. The primary endpoint of the trial was to compare the overall survival (OS) in MRD-patients who received Blincyto in conjunction with chemotherapy to that of patients who received chemotherapy alone.2,3

Results found that the three-year OS in the Blincyto chemotherapy combination arm was 84.8%, compared with 69% in the chemotherapy arm. Additionally, OS at five years was 82.4% for the combination arm compared with 62.5% in the chemotherapy arm, with a median follow-up of 4.5 years.

In terms of safety, common adverse events associated with Blincyto included pyrexia, infusion-related reactions, headache, infection, musculoskeletal pain, neutropenia, nausea, anemia, thrombocytopenia, and diarrhea.1

"In the E1910 study, blinatumomab reduced risk of death and showed a remarkable improvement in overall survival," said Selina M. Luger, MD, professor of hematology-oncology, the University of Pennsylvania's Perelman School of Medicine and Abramson Cancer Center, chair of the ECOG-ACRIN Leukemia Committee, investigator on the study, in the press release. "This approval redefines the standard of care for patients with B-ALL and provides them with a more effective treatment option than standard chemotherapy alone."

Between 2014 and 2020, it was estimated that 72% of patients diagnosed with ALL survived five years or more. In 2021, it was also estimated that there were around 115,294 people living with ALL in the United States. The disease is most common in children, adolescents, and young adults between the ages of 15-39 years. It is expected that 0.1% of the population will develop ALL in their lifetime, with an estimated 1,330 people expected to die from it in 2024.4

"The risk of B-ALL recurrence after the initial phase of treatment is relatively high, making this approval for patients noteworthy," said E. Anders Kolb, MD, president, CEO, The Leukemia & Lymphoma Society, in the press release. "B-ALL is the most common type of ALL and having another effective option available earlier in a patient's treatment journey is critical for clinicians who are working to give these patients more time with their loved ones."


1. FDA APPROVES BLINCYTO® (BLINATUMOMAB) IN CD19-POSITIVE PHILADELPHIA CHROMOSOME-NEGATIVE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) IN THE CONSOLIDATION PHASE. Amgen. June 14, 2024. Accessed June 17, 2024. https://www.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. Consolidation Therapy with Blinatumomab Improves Overall Survival in Newly Diagnosed Adult Patients with B-Lineage Acute Lymphoblastic Leukemia in Measurable Residual Disease Negative Remission: Results from the ECOG-ACRIN E1910 Randomized Phase III National Cooperative Clinical Trials Network Trial. ASH Publications. December 6, 2022. Accessed June 17, 2024. https://ashpublications.org/blood/article/140/Supplement%202/LBA-1/493429/Consolidation-Therapy-with-Blinatumomab-Improves

3. Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia. Clinicaltrials.gov. December 15, 2023. Accessed June 17, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT02003222

4. Cancer Stat Facts: Leukemia — Acute Lymphocytic Leukemia (ALL). National Cancer Institute. Accessed June 17, 2024. https://seer.cancer.gov/statfacts/html/alyl.html

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