Amgen (NASDAQ:AMGN) has exciting news to share with the announcement of the approval of BLINCYTO® (blinatumomab) by the U.S. Food and Drug Administration (FDA). This approval is for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status.
“This approval is a significant milestone in the fight against B-ALL, a highly aggressive blood cancer that poses a high unmet medical need. BLINCYTO has been instrumental in helping thousands of B-ALL patients over the last decade. Today’s approval in the frontline consolidation phase, regardless of MRD status, allows us to reach more patients than ever with this groundbreaking Bispecific T-cell Engager (BiTE®) therapy,” said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen.
The approval is based on the Phase 3 E1910 clinical trial led by the ECOG-ACRIN Cancer Research Group, which studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment. The trial showed that adding BLINCYTO to multiphase consolidation chemotherapy resulted in superior overall survival (OS) compared to chemotherapy alone. The 3-year OS was 84.8% in the BLINCYTO plus chemotherapy arm and 69% in the chemotherapy arm, with a hazard ratio for OS of 0.42. With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the BLINCYTO plus chemotherapy arm and 62.5% in the chemotherapy arm.
Dr. Selina M. Luger, a professor of hematology-oncology at the University of Pennsylvania’s Perelman School of Medicine and chair of the ECOG-ACRIN Leukemia Committee, commented on the study results, stating, “In the E1910 study, blinatumomab reduced the risk of death and showed a remarkable improvement in overall survival. This approval sets a new standard of care for B-ALL patients, providing them with a more effective treatment option than standard chemotherapy alone.”
E. Anders Kolb, M.D., president, and chief executive officer of The Leukemia & Lymphoma Society emphasized the significance of the approval for patients with B-ALL, noting the high risk of recurrence after initial treatment. Having an additional effective treatment option available earlier in a patient’s treatment journey is crucial for clinicians working to give these patients more quality time with their loved ones.
The E1910 study was independently designed and conducted, sponsored by the ECOG-ACRIN with public funding from the National Cancer Institute (NCI). Amgen provided BLINCYTO and support through an NCI Cooperative Research and Development Agreement.
About Acute Lymphoblastic Leukemia (ALL)
ALL, also known as acute lymphoblastic leukemia, is a fast-growing blood cancer that originates in the bone marrow and can spread to other parts of the body. It is a rare disease, with 6,540 new cases diagnosed in the U.S. in 2023, affecting both children and adults. B-ALL specifically begins in immature cells that would typically develop into B-cell lymphocytes, vital white blood cells that grow in the bone marrow. B-ALL accounts for approximately 75% of ALL cases in adults.
About BLINCYTO® (blinatumomab)
BLINCYTO is a pioneering BiTE® immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE® molecules work by engaging the body’s immune system to detect and target malignant cells, specifically activating T cells to attack cancer cells. By bringing T cells in proximity to cancer cells, the T cells can inject toxins, triggering cancer cell death. BiTE® immuno-oncology therapies are under investigation for their potential to treat a broad range of cancers.
BLINCYTO was granted breakthrough therapy and Priority Review designations by the U.S. FDA and is approved for various indications in the U.S. and the European Union (EU).
Indications for BLINCYTO include the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with:
1. Philadelphia chromosome-negative disease in the consolidation phase of multiphase chemotherapy.
2. Minimal residual disease (MRD) greater than or equal to 0.1% in the first or second complete remission.
3. Relapsed or refractory disease.
The safety of BLINCYTO has been evaluated in clinical studies, with common adverse reactions including pyrexia, infusion-related reactions, headache, infection, musculoskeletal pain, neutropenia, nausea, anemia, thrombocytopenia, and diarrhea.
Dosage and administration guidelines specify that BLINCYTO is administered as a continuous intravenous infusion using an infusion pump to ensure accurate dosing.
Amgen’s commitment to innovation and patient care is reflected in its ongoing efforts to develop and deliver innovative medicines for patients facing challenging diseases. For more information about Amgen and its groundbreaking therapies, visit their website at [Amgen.com](http://amgen.com).
By continually striving for excellence, Amgen remains at the forefront of the biotechnology industry, leveraging technology and genetic data to address unmet medical needs and improve patient outcomes. With a diverse pipeline encompassing treatments for cancer, heart disease, osteoporosis, inflammatory diseases, and rare conditions, Amgen is dedicated to making a meaningful impact on the healthcare landscape.
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**About Amgen**
Amgen is a trailblazer in discovering, developing, manufacturing, and delivering innovative medicines to combat some of the world’s most challenging diseases. With a rich history spanning over 40 years, Amgen continues to lead the way in biotechnology, leveraging technology and genetic insights to push boundaries and drive innovation across various therapeutic areas. Amgen’s robust pipeline, comprising both existing and emerging treatments for cancer, heart disease, osteoporosis, inflammatory conditions, and rare diseases, underscores its commitment to improving patient lives.
In 2024, Amgen was recognized as one of the “World’s Most Innovative Companies” by Fast Company and named one of “America’s Best Large Employers” by Forbes, highlighting its dedication to excellence and employee well-being. As a constituent of the Dow Jones Industrial Average® and Nasdaq-100 Index®, Amgen holds a prominent position among leading non-financial companies in the industry.
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**Forward-Looking Statements**
This news release contains forward-looking statements reflecting Amgen’s current expectations and beliefs. These statements involve risks and uncertainties that could cause actual results to differ materially from projected outcomes. Amgen does not undertake to update any forward-looking statements in this document based on new information, future events, or other factors.
For further inquiries, please contact:
– Elissa Snook, 609-251-1407 (media)
– Justin Claeys, 805-313-9775 (investors)
*Editor’s note: Dr. Luger has received honoraria for an Amgen-sponsored educational symposium.*
References:
1. National Cancer Institute. [Acute Lymphoblastic Leukemia Facts](https://seer.cancer.gov/statfacts/html/alyl.html). Accessed on February 8, 2024.
2. Terwilliger T, et al. *Blood Cancer J*. doi:10.1038/bcj.2017.53.
3. Cancer.org. [About Acute Lymphoblastic Leukemia](https://www.cancer.org/cancer/types/acute-lymphocytic-leukemia/about/what-is-all.html). Accessed on February 8, 2024.
4. Leukemia & Lymphoma Society. [ALL Research](https://www.lls.org/research/acute-lymphoblastic-leukemia-all#:~:text=B%2DALL%20is%20more%20common,about%2075%20percent%20of%20cases). Accessed on February 8, 2024.