New U.S. FDA Approval Expands Use of Amgen’s BLINCYTO for Leukemia
Nikhil Prasad Fact checked by:Thailand Medical News Team Jun 17, 2024 4 months, 1 week, 1 day, 10 hours, 14 minutes ago
Pharma News: The US Food and Drug Administration (FDA) has granted approval for Amgen’s BLINCYTO (blinatumomab) to treat CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in patients aged over one month. This approval is significant for both adult and pediatric patients in the consolidation phase of their treatment.
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New U.S. FDA Approval Expands Use of Amgen’s BLINCYTO for Leukemia
A Milestone in Leukemia Treatment
The FDA’s decision is based on the positive results from the Phase III E1910 clinical trial, spearheaded by the ECOG-ACRIN Cancer Research Group. This trial evaluated the effectiveness of BLINCYTO in the postinduction consolidation treatment phase for newly diagnosed patients. The primary goal was to deepen remission and achieve long-term responses.
Key Findings from the E1910 Clinical Trial
Amgen’s drug experts told
Pharma News journalist at TMN that a recent clinical trial demonstrated that adding BLINCYTO to the standard consolidation chemotherapy significantly improved overall survival (OS) rates compared to chemotherapy alone. The three-year OS rate was an impressive 84.8% for patients receiving BLINCYTO combined with chemotherapy, compared to 69% for those on chemotherapy alone. With a median follow-up of four and a half years, the five-year OS was 82.4% for the BLINCYTO and chemotherapy group versus 62.5% for the chemotherapy-only group.
Jay Bradner, Amgen's Executive Vice President of Research and Development, highlighted the importance of this approval: “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. The 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.”
How BLINCYTO Works
BLINCYTO is a BiTE immuno-oncology therapy that targets CD19 surface antigens on B cells. The therapy works by engaging the body's T-cells to attack cancerous B-cells. It has already secured breakthrough therapy and priority review designations from the FDA. The drug is approved in the US for several indications, including CD19-positive B-ALL in first or second complete remission with measurable residual disease (MRD) ≥0.1%, and relapsed or refractory CD19-positive B-ALL in both adults and pediatric patients aged above one month.
Efficacy and Safety Evaluations
In the Phase III E1910 study (NCT02003222), adult patients with newly diagnosed Ph-negative BCP ALL who achieved hematologic complete remission (CR) or CR with incomplete peripheral blood count recovery (CRi) after induction and intensification chemotherapy were randomized to receive either a consolidation regimen of multiple BLINCYTO monotherapy cycles combined with intensive chemotherapy or intensive chemotherapy alone. The study's major efficacy
outcome was overall survival, where BLINCYTO demonstrated superior results.
In a separate study, 20120215 (NCT02393859), pediatric and young adult patients with Ph-negative BCP ALL were also assessed. The findings showed that the five-year OS was 78.4% for patients receiving BLINCYTO versus 41.4% for those undergoing intensive combination chemotherapy.
Adverse Reactions
The most common adverse reactions in the BLINCYTO arm of the E1910 study included neutropenia, thrombocytopenia, anemia, leukopenia, headache, infection, nausea, lymphopenia, diarrhea, musculoskeletal pain, and tremor. In the pediatric study 20120215, frequent adverse reactions included pyrexia, nausea, headache, rash, hypogammaglobulinemia, and anemia.
Expedited Review and International Collaboration
The U.S. FDA’s approval process for BLINCYTO involved expedited programs, including Project Orbis, which facilitates the concurrent submission and review of oncology drugs among international partners. For this review, the FDA collaborated with agencies in Brazil, Canada, Switzerland, and the UK. The Real-Time Oncology Review (RTOR) pilot program was also utilized, streamlining data submission and assessment.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-blinatumomab-consolidation-cd19-positive-philadelphia-chromosome-negative-b-cell
BLINCYTO’s Market Impact
Amgen reported that BLINCYTO generated $244 million in sales during the first quarter, driven by prescriptions for B-cell precursor acute lymphoblastic leukemia. The FDA’s latest approval is expected to further expand the use of this drug, providing a critical treatment option for a broader patient population.
Conclusion
The FDA’s approval of BLINCYTO marks a significant advancement in the treatment of acute lymphoblastic leukemia, offering hope to patients and their families. As BLINCYTO continues to demonstrate its efficacy and safety, it solidifies its role as a transformative therapy in the fight against this aggressive blood cancer.
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