Calaspargase pegol-mknl - Biologic Drug Details

Summary for calaspargase pegol-mknl

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for calaspargase pegol-mknl

Established Pharmacologic Class	Asparagine-specific Enzyme
Chemical Structure	Asparaginase

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for calaspargase pegol-mknl Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for calaspargase pegol-mknl Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for calaspargase pegol-mknl Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Calaspargase Pegol-mknl

Introduction

Calaspargase pegol-mknl, marketed as Asparlas, is a significant advancement in the treatment of acute lymphoblastic leukemia (ALL) in pediatric and young adult patients. Approved by the FDA in December 2018, this asparagine-specific enzyme has introduced several key changes in the market dynamics and financial trajectory of ALL treatment.

Approval and Regulatory Framework

The FDA approval of calaspargase pegol-mknl was based on its ability to maintain nadir serum asparaginase activity above 0.1 U/mL when administered every 3 weeks, a longer interval compared to other pegaspargase products[3][5].

Market Need and Unmet Needs

The approval of calaspargase pegol-mknl addresses a significant unmet need among patients who are eligible for standard induction of ALL treatment but may experience adverse reactions or intolerance to other asparaginase products. Patients treated with calaspargase pegol-mknl benefit from less frequent dosing, which can improve compliance and reduce the burden on healthcare systems[2].

Clinical Evidence and Efficacy

Clinical trials, including the COG AALL07P4 and DFCI 11-001 studies, have demonstrated the pharmacokinetic and pharmacodynamic comparability of calaspargase pegol-mknl to pegaspargase. These studies showed that calaspargase pegol-mknl maintained adequate asparaginase activity levels and had a similar safety profile to pegaspargase when administered every 3 weeks[1][2].

Safety Profile

While the overall safety profile of calaspargase pegol-mknl is similar to that of pegaspargase, there are some notable differences in adverse reactions. Calaspargase pegol-mknl has been associated with a higher incidence of pancreatitis and venous thromboembolism (VTE), particularly in T-cell ALL patients. However, it has a lower incidence of allergic reactions compared to pegaspargase[4].

Economic Evaluation

The economic evaluation of calaspargase pegol-mknl involves several factors, including the cost of the drug, the frequency of dosing, and the impact on healthcare resource utilization. The less frequent dosing schedule of calaspargase pegol-mknl can reduce the overall cost of treatment and minimize the need for hospital visits and administration of the drug. However, the drug itself may be more expensive than its counterparts, which can affect the overall financial trajectory[2].

Cost Comparison and Financial Impacts

The cost comparison between calaspargase pegol-mknl and other asparaginase products is complex. While the drug may be more expensive per dose, the reduced frequency of administration can lead to cost savings over the treatment period. Additionally, the reduction in adverse events and the need for alternative therapies can further mitigate costs[2].

Reimbursement and Access

The reimbursement landscape for calaspargase pegol-mknl varies by region. In Canada, for example, the drug has undergone a thorough reimbursement review by CADTH, which considered factors such as the initiation of therapy, prescribing practices, and system and economic issues. The appropriate setting for treatment with calaspargase pegol-mknl is typically acute leukemia treatment centers with leukemia specialists[2].

Market Competition

Calaspargase pegol-mknl competes with other asparaginase products, including pegaspargase. The market competition is driven by factors such as efficacy, safety, dosing frequency, and cost. The unique selling point of calaspargase pegol-mknl is its longer dosing interval, which can offer a competitive advantage in terms of patient compliance and healthcare resource utilization[3].

Patient and Clinician Perspectives

From a patient perspective, the less frequent dosing of calaspargase pegol-mknl can significantly improve the quality of life by reducing the number of hospital visits and the burden of treatment. Clinicians appreciate the similar safety profile and the ease of administration, which can streamline treatment protocols[2].

Real-World Evidence and Post-Market Surveillance

Post-market studies have provided valuable insights into the real-world use of calaspargase pegol-mknl. These studies have highlighted the need for continued monitoring of asparaginase activity and the management of adverse events such as pancreatitis and VTE. Real-world data can help in refining treatment guidelines and improving patient outcomes[4].

Financial Projections and Growth Potential

The financial trajectory of calaspargase pegol-mknl is promising due to its unique positioning in the market. As more patients and healthcare providers adopt this treatment, the revenue is expected to grow. The drug's orphan product designation also provides certain financial incentives, which can further boost its market performance[3].

Key Takeaways

• Approval and Indications: Calaspargase pegol-mknl is FDA-approved for the treatment of ALL in pediatric and young adult patients.
• Clinical Evidence: Demonstrated pharmacokinetic and pharmacodynamic comparability to pegaspargase.
• Safety Profile: Higher incidence of pancreatitis and VTE, lower incidence of allergic reactions.
• Economic Evaluation: Less frequent dosing can reduce overall treatment costs despite higher per-dose costs.
• Reimbursement and Access: Varies by region, with specific recommendations for treatment settings.
• Market Competition: Competes with other asparaginase products, offering a longer dosing interval.
• Patient and Clinician Perspectives: Improves quality of life and streamlines treatment protocols.

FAQs

1. What is calaspargase pegol-mknl used for?

   • Calaspargase pegol-mknl is used as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) in pediatric and young adult patients.

2. How is calaspargase pegol-mknl administered?

   • It is administered intravenously at a dose of 2,500 units/m² every 3 weeks.

3. What are the common adverse reactions associated with calaspargase pegol-mknl?

   • Common adverse reactions include elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting studies.

4. How does the safety profile of calaspargase pegol-mknl compare to pegaspargase?

   • The overall safety profile is similar, but calaspargase pegol-mknl has a higher incidence of pancreatitis and VTE, particularly in T-cell ALL patients, and a lower incidence of allergic reactions.

5. What are the economic benefits of using calaspargase pegol-mknl?

   • The less frequent dosing schedule can reduce the overall cost of treatment and minimize the need for hospital visits and administration of the drug.

Sources

1. FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia - PubMed[1]
2. Calaspargase Pegol (Asparlas) - Canada's Drug Agency - CDA-AMC[2]
3. FDA Approves Longer-Acting Calaspargase Pegol-mknl for ALL - FDA[3]
4. A Real-World, Single Institution, Post-Market Comparison of CalPEG and PEGasp - ASH Publications[4]
5. Calaspargase Pegol-mknl | Leukemia and Lymphoma Society - LLS[5]

Last updated: 2024-12-18