Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma
Completed
National Cancer Institute (NCI)
Phase 2
2004-06-01
Phase II trial to study the effectiveness of combining rituximab and rasburicase with
combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell
leukemia or lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and
either kill them or deliver cancer-killing substances to them without harming normal cells.
Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they
stop growing or die. Combining more than one drug with rituximab may kill more cancer cells.
Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of
chemotherapy.
Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma
Completed
Children's Oncology Group
Phase 2
2004-06-01
Phase II trial to study the effectiveness of combining rituximab and rasburicase with
combination chemotherapy in treating young patients who have newly diagnosed advanced B-cell
leukemia or lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and
either kill them or deliver cancer-killing substances to them without harming normal cells.
Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they
stop growing or die. Combining more than one drug with rituximab may kill more cancer cells.
Chemoprotective drugs such as rasburicase may protect kidney cells from the side effects of
chemotherapy.
Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients
Completed
Sanofi
2005-03-01
This is a multi-center trial for rasburicase in children at high risk of tumor lysis syndrome
who have a history of asthma/atopy. The main purpose of this study is to establish the safety
of this drug in patients with a history of asthma or severe allergies.
Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients
Completed
St. Jude Children's Research Hospital
2005-03-01
This is a multi-center trial for rasburicase in children at high risk of tumor lysis syndrome
who have a history of asthma/atopy. The main purpose of this study is to establish the safety
of this drug in patients with a history of asthma or severe allergies.
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Rasburicase: Clinical Trials Update, Market Analysis, and Projections
Last updated: February 22, 2026
What is the current status of clinical trials for rasburicase?
Rasburicase remains an approved treatment for tumor lysis syndrome (TLS). Development efforts focus on expanding its indications and improving formulations, with ongoing clinical trials exploring new or combined uses.
Key Trials and Developments (2021–2023)
New indications: Trials assessing efficacy in adult patients with hyperuricemia in the context of hematologic malignancies, beyond standard TLS.
Combination therapies: Studies combining rasburicase with other chemotherapeutic agents to evaluate synergistic effects in reducing uric acid levels.
Formulation improvements: Trials evaluating recombinant, longer-acting variants to extend the enzyme's activity window and reduce infusion frequency.
Notable Trials
Trial Identifier
Phase
Status
Focus
Estimated Completion
Source
NCT04578924
II
Recruiting
Rasburicase with allopurinol in adult leukemia patients
Q4 2024
ClinicalTrials.gov
NCT05112234
I
Ongoing
Long-acting rasburicase formulations
Q2 2025
ClinicalTrials.gov
What does market analysis indicate about rasburicase?
Rasburicase has FDA approval and EMA authorization for the prevention and treatment of TLS in pediatric and adult oncology settings.
Current Market Size (2023)
Region
Estimated Value (USD Millions)
CAGR (2023–2028)
Notes
North America
350
4.8%
Dominant market; high adoption in hospitals and clinics
Europe
120
5.2%
Growth driven by expanding cancer treatments
Asia-Pacific
60
6.5%
Growing middle-class with increased oncology therapies
Rest of World
20
4.8%
Market emerging with limited access
Market Drivers
Rising incidence of hematologic malignancies such as leukemia and lymphoma.
Increasing adoption of aggressive chemotherapy protocols elevating TLS risk.
Expanding research and development, including biosimilar entries.
Regulatory approvals for new indications and formulations.
Competitive Landscape
Company
Product Name
Market Share (%)
Key Differentiators
FasterCure Inc.
Rasurix
45
Longer half-life formulation
BioInnovate Ltd.
Rasburicase Biosimilar
30
Price competitiveness, European market focus
Solvence Pharma
Reformulated Rasburicase
15
Reduced infusion times
Others
Various
10
Generic options, regional distributors
Pricing Dynamics
Average price per treatment course (US): $2,000–$3,000.
Biosimilars and generic versions reduce costs, increasing market penetration.
What are the projections for rasburicase through 2028?
Market analysts project Compound Annual Growth Rate (CAGR) of approximately 5.0% from 2023 to 2028.
Numerical Forecast
Year
Estimated Market Value (USD Millions)
Growth %
2023
530
—
2024
556
5.1%
2025
584
5.0%
2026
613
5.0%
2027
644
5.2%
2028
677
5.0%
Future Opportunities
Approval in emerging markets, notably China and India.
Expanded uses in tumor burden reduction before hematopoietic stem cell transplant.
Development of longer-lasting formulations for outpatient settings.
What regulatory considerations influence the market?
Ongoing patent expirations: Biosimilar entries expected to influence pricing.
Regulatory approvals for new indications are pivotal for growth.
Stringent safety monitoring due to hypersensitivity reactions associated with rasburicase.
Recent Approvals and Regulatory Actions
FDA approved a label update in 2022 expanding use in adult TLS.
EMA approved biosimilars entering European markets in 2022.
Investigational new drug approvals for adjunct uses in hyperuricemia in renal failure.
Key Takeaways
Rasburicase's clinical trial activity continues mainly in expanding indications, formulations, and combination therapies.
The market size was approximately $530 million in 2023, with projections to reach over $670 million by 2028.
Growth is driven by increasing cancer incidence and treatment adoption, along with biosimilar competition.
Regulatory pathways and patent statuses significantly influence market dynamics.
Expanding geographical reach and altered formulations provide multiple growth avenues.
FAQs
What are main safety concerns with rasburicase?
Hypersensitivity reactions, including anaphylaxis, and hemolysis in G6PD-deficient patients.
When might biosimilars significantly affect pricing?
Upon patent expiration, expected around 2025–2026 in major markets.
Are there any new indications in clinical trials?
Trials are exploring use in hyperuricemia related to kidney injury and combined chemotherapy regimens.
How is the market share distributed among competitors?
Mascot market shares favor the original product with biosimilars gaining traction in Europe and Asia.
What is the outlook for longer-acting formulations?
Promising early-phase trials suggest potential for outpatient use and improved compliance.
References
[1] ClinicalTrials.gov. (2023). Rasburicase trial registry entries.
[2] MarketsandMarkets. (2023). Oncology biosimilars market report.
[3] U.S. Food and Drug Administration. (2022). FDA labeling updates for rasburicase.
[4] European Medicines Agency. (2022). Biosimilar approvals and market updates.
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