Tositumomab and iodine i-131 tositumomab - Biologic Drug Details

Summary for tositumomab and iodine i-131 tositumomab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1

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 tositumomab and iodine i-131 tositumomab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for tositumomab and iodine i-131 tositumomab Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for tositumomab and iodine i-131 tositumomab Derived from Patent Text Search

No patents found based on company disclosures

Tositumomab and iodine i-131 tositumomab Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Tositumomab and Iodine I-131 Tositumomab

Introduction

Tositumomab, combined with iodine I-131, has been a significant player in the field of radioimmunotherapy, particularly for the treatment of non-Hodgkin lymphoma (NHL). Despite its initial promise, the market dynamics and financial trajectory of this biologic drug have been complex and challenging.

Market Size and Growth

The broader radioimmunotherapy market, which includes drugs like tositumomab and iodine I-131 tositumomab, is projected to grow significantly. The global radioimmunotherapy market is expected to expand from USD 2.68 billion in 2024 to around USD 12.70 billion by 2034, at a CAGR of 16.85% during the forecast period[1].

Initial Promise and Approval

Iodine-131 tositumomab, marketed as Bexxar, was introduced in 2003 for the treatment of refractory non-Hodgkin lymphoma. It showed significant efficacy in clinical trials, particularly in patients who had failed multiple prior chemotherapy regimens. A pivotal study demonstrated that a single course of iodine I-131 tositumomab was more efficacious than the last qualifying chemotherapy regimens, with a higher response rate and longer duration of response[2].

Market Performance and Usage

Despite its initial approval and promising clinical results, the market performance of Bexxar was disappointing. The drug failed to gain widespread acceptance among oncologists due to several factors. These included logistical challenges related to dosimetry and administration, concerns about radiation effects, and competition from newer agents. By 2014, the usage of Bexxar had declined significantly, with only 55 doses sold in North America in 2013[3][4].

Discontinuation and Market Withdrawal

The declining usage and lack of demonstrated superiority over existing treatments led to the formal withdrawal of marketing approval for Bexxar in February 2014. This marked the end of its commercial availability, despite its potential as a targeted radiopharmaceutical therapy[3][4].

Financial Challenges

The financial trajectory of Bexxar was heavily impacted by its low market penetration and the high costs associated with its development, manufacturing, and delivery. The drug required specialized infrastructure and multiple visits for dosimetry, which added to its complexity and cost. These economic considerations, combined with the lack of additional funding, contributed to its commercial failure[4].

Lessons Learned

The story of Bexxar highlights several key lessons for the development and commercialization of innovative cancer therapies:

• Efficacy and Safety: A novel therapy must demonstrate clear advantages over existing treatments in terms of efficacy, safety, convenience, and cost.
• Infrastructure and Accessibility: Healthcare systems need to develop specialized infrastructure to support advanced therapies like radiopharmaceuticals.
• Economic Considerations: Strategic planning is necessary to ensure affordability and market penetration, given the high costs associated with these therapies[4].

Potential for Revival

There is recent speculation about a potential relaunch of iodine-131 tositumomab by private investors. Advances in radiopharmaceutical technology and a growing focus on personalized medicine could address some of the challenges that hindered its initial adoption. However, the lack of additional details and funding constraints remain significant barriers[4].

Regional Market Dynamics

The radioimmunotherapy market, including drugs like tositumomab and iodine I-131 tositumomab, is expected to see significant growth in various regions. North America is currently the largest market, but the Asia Pacific region is projected to host the fastest-growing radioimmunotherapy market due to the rapidly growing healthcare industry, rising cancer incidence rates, and high investment in cancer research[1].

Competitive Landscape

The competitive landscape for radioimmunotherapy includes other radioisotopes like yttrium-90, which is used in treatments such as 90Y-ibritumomab tiuxetan. This treatment has shown efficacy in managing non-Hodgkin lymphoma and other cancers, and its usage is expected to expand in the coming years[1][3].

Key Takeaways

• The global radioimmunotherapy market is expected to grow significantly, driven by the increasing demand for advanced cancer treatments.
• Iodine-131 tositumomab (Bexxar) showed initial promise but failed to gain market traction due to logistical, safety, and economic challenges.
• The drug was withdrawn from the market in 2014 but may see a potential revival with advances in technology and personalized medicine.
• The financial trajectory of such therapies is heavily influenced by factors such as infrastructure, accessibility, and economic viability.

FAQs

What is the current market size of the radioimmunotherapy market?

The global radioimmunotherapy market size was USD 2.68 billion in 2024 and is expected to reach around USD 12.70 billion by 2034[1].

Why was iodine-131 tositumomab (Bexxar) withdrawn from the market?

Bexxar was withdrawn from the market due to its extremely limited use, logistical challenges, and declining physician interest, despite its initial promise and FDA approval[3][4].

What are the main challenges faced by radiopharmaceuticals like Bexxar?

The main challenges include logistical complexities, concerns about radiation effects, competition from newer agents, and high development, manufacturing, and delivery costs[3][4].

Is there a potential for the revival of iodine-131 tositumomab?

Yes, there is speculation about a potential relaunch by private investors, driven by advances in radiopharmaceutical technology and a growing focus on personalized medicine[4].

Which region is expected to host the fastest-growing radioimmunotherapy market?

The Asia Pacific region is projected to host the fastest-growing radioimmunotherapy market due to the rapidly growing healthcare industry and rising cancer incidence rates[1].

Sources

1. Precedence Research, "Radioimmunotherapy Market Size, Share and Trends 2024 to 2034"
2. PubMed, "Pivotal study of iodine I 131 tositumomab for chemotherapy-refractory low-grade or transformed low-grade non-Hodgkin's lymphoma"
3. Nuclear Regulatory Commission, "Request for a Meeting Regarding 131I-Tositumomab"
4. OpenMedScience, "The Rise and Fall of Iodine-131 Tositumomab: Bexxar's Story"
5. Red Journal, "Iodine-131 tositumomab (Bexxar) in a radiation oncology environment"